id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
12,269 |
ApprovletS037.doc (clean copy 27March02)
Page 4 of 39
Rx only
VIDEX
(didanosine)
VIDEX (didanosine) Chewable/Dispersible Buffered Tablets
VIDEX (didanosine) Buffered Powder for Oral Solution
VIDEX (didanosine) Pediatric Powder for Oral Solution
(Patient Information Leaflet Included)
WARNING
FATAL AN... | custom-source | 2025-02-12T13:46:54.087304 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf', 'application_number': 20155, 'submission_type': 'SUPPL ', 'submission_number': 28} |
12,268 |
ApprovletS036.doc (clean copy 11/7/01)
Page 3 of 39
Rx only
VIDEX
(didanosine)
VIDEX (didanosine) Chewable/Dispersible Buffered Tablets
VIDEX (didanosine) Buffered Powder for Oral Solution
VIDEX (didanosine) Pediatric Powder for Oral Solution
(Patient Information Leaflet Included)
WARNING
FATAL AND ... | custom-source | 2025-02-12T13:46:54.116899 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20155s27lbl.pdf', 'application_number': 20155, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,271 |
January 27, 2003
Page 4 of 70
VDXribaJan03FDA.doc (clean)
Rx only
VIDEX
(didanosine)
VIDEX (didanosine) Chewable/Dispersible Buffered Tablets
VIDEX (didanosine) Buffered Powder for Oral Solution
VIDEX (didanosine) Pediatric Powder for Oral Solution
(Patient Information Leaflet Included)
WARNING ... | custom-source | 2025-02-12T13:46:54.360892 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20154slr042,20156slr033,20155slr032,21183slr007videx_lbl.pdf', 'application_number': 20155, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,272 | NDA 20-154/S-049
NDA 20-155/S-038
NDA 20-156/S-039
NDA 21-183/S-015
Page 4 of 75
Rx only
VIDEX® (didanosine)
VIDEX® (didanosine) Chewable/Dispersible Buffered Tablets
VIDEX® (didanosine) Pediatric Powder for Oral Solution
(Patient Information Leaflet Included)
WARNING
FATAL AND NO... | custom-source | 2025-02-12T13:46:54.578090 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf', 'application_number': 20155, 'submission_type': 'SUPPL ', 'submission_number': 38} |
12,274 |
ApprovletS037.doc (clean copy 27March02)
Page 4 of 39
Rx only
VIDEX
(didanosine)
VIDEX (didanosine) Chewable/Dispersible Buffered Tablets
VIDEX (didanosine) Buffered Powder for Oral Solution
VIDEX (didanosine) Pediatric Powder for Oral Solution
(Patient Information Leaflet Included)
WARNING
FATAL AN... | custom-source | 2025-02-12T13:46:54.704094 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s37lbl.pdf', 'application_number': 20156, 'submission_type': 'SUPPL ', 'submission_number': 29} |
12,275 |
Page 4 of 39
Rx only
VIDEX
(didanosine)
VIDEX (didanosine) Chewable/Dispersible Buffered Tablets
VIDEX (didanosine) Buffered Powder for Oral Solution
VIDEX (didanosine) Pediatric Powder for Oral Solution
(Patient Information Leaflet Included)
WARNING
FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED ... | custom-source | 2025-02-12T13:46:54.964537 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf', 'application_number': 20156, 'submission_type': 'SUPPL ', 'submission_number': 31} |
12,273 | ApprovletS035.doc (clean copy 1/10/01)
Page 4 of 33
Rx only
VIDEX
(didanosine)
VIDEX (didanosine) Chewable/Dispersible Buffered Tablets
VIDEX (didanosine) Buffered Powder for Oral Solution
VIDEX (didanosine) Pediatric Powder for Oral Solution
(Patient Information Leaflet Included)
WARNING
FATAL AND NONFATAL PA... | custom-source | 2025-02-12T13:46:55.023694 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20156s27lbl.pdf', 'application_number': 20156, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,276 |
Page 4 of 39
Rx only
VIDEX
(didanosine)
VIDEX (didanosine) Chewable/Dispersible Buffered Tablets
VIDEX (didanosine) Buffered Powder for Oral Solution
VIDEX (didanosine) Pediatric Powder for Oral Solution
(Patient Information Leaflet Included)
WARNING
FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED ... | custom-source | 2025-02-12T13:46:55.152720 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20154s40,s41lbl.pdf', 'application_number': 20156, 'submission_type': 'SUPPL ', 'submission_number': 32} |
12,279 | NDA 20-154/S-050
NDA 20-155/S-039
NDA 20-156/S-040
NDA 21-183/S-016
Page 5 of 72
Rx only
VIDEX® (didanosine)
VIDEX® (didanosine) Pediatric Powder for Oral Solution
(Patient Information Leaflet Included)
WARNING
FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING
THERAPY WITH VIDEX USED ALONE OR IN... | custom-source | 2025-02-12T13:46:55.455540 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s50,20155s39,20156s40,21183s16lbl.pdf', 'application_number': 20156, 'submission_type': 'SUPPL ', 'submission_number': 40} |
12,278 | NDA 20-154/S-049
NDA 20-155/S-038
NDA 20-156/S-039
NDA 21-183/S-015
Page 4 of 75
Rx only
VIDEX® (didanosine)
VIDEX® (didanosine) Chewable/Dispersible Buffered Tablets
VIDEX® (didanosine) Pediatric Powder for Oral Solution
(Patient Information Leaflet Included)
WARNING
FATAL AND NO... | custom-source | 2025-02-12T13:46:55.752183 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020154s49,20155s38,20156s39,21183s15lbl.pdf', 'application_number': 20156, 'submission_type': 'SUPPL ', 'submission_number': 39} |
12,280 |
... | custom-source | 2025-02-12T13:46:55.875058 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020156s044lbl.pdf', 'application_number': 20156, 'submission_type': 'SUPPL ', 'submission_number': 44} |
12,277 | NDA 20-154/S-044
NDA 20-155/S-034
NDA 20-156/S-035
NDA 21-183/S-010
Page 3
Rx only
VIDEX EC (didanosine)
VIDEX EC (didanosine) Delayed-Release Capsules
Enteric-Coated Beadlets
(Patient Information Leaflet Included)
WARNING
FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING
THERAPY WITH DIDANOSINE... | custom-source | 2025-02-12T13:46:55.943373 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20154slr044,20155slr034,20156slr035,21183s010_videx_lbl.pdf', 'application_number': 20156, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,281 |
... | custom-source | 2025-02-12T13:46:56.153589 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020156s046lbl.pdf', 'application_number': 20156, 'submission_type': 'SUPPL ', 'submission_number': 46} |
12,284 |
DIANEAL Peritoneal Dialysis Solution
For intraperitoneal administration only
... | custom-source | 2025-02-12T13:46:56.266982 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020183s024lbl.pdf', 'application_number': 20163, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,283 |
ACTHREL®
(corticorelin ovine triflutate for inj... | custom-source | 2025-02-12T13:46:56.317847 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020162s010lbl.pdf', 'application_number': 20162, 'submission_type': 'SUPPL ', 'submission_number': 10} |
12,282 |
... | custom-source | 2025-02-12T13:46:56.483538 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020156s051lbl.pdf', 'application_number': 20156, 'submission_type': 'SUPPL ', 'submission_number': 51} |
12,285 | NDA 20-164/S-036
Page 1
Rx only
Rev. ---
508539D
SPINAL / EPIDURAL HEMATOMAS
When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled
to be anticoagulated with low molecular weight heparins or heparinoids for prevention of thromboembolic complications
a... | custom-source | 2025-02-12T13:46:56.643916 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20164S36lbl.pdf', 'application_number': 20164, 'submission_type': 'SUPPL ', 'submission_number': 37} |
12,287 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use Lovenox safely and effectively. See full prescribing
information for Lovenox.
Lovenox® (enoxaparin sodium injection) for subcutaneous and
intravenous use
Initial U.S. Approval: 1993
WARNING: SPINAL/EPIDU... | custom-source | 2025-02-12T13:46:56.875722 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022138,020164s075lbl.pdf', 'application_number': 20164, 'submission_type': 'SUPPL ', 'submission_number': 75} |
12,286 | NDA 20-164/S-055
Page 3
Rx only
Rev. XXXX
SPINAL / EPIDURAL HEMATOMAS
When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients
anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids
for prevention of thromboembolic c... | custom-source | 2025-02-12T13:46:57.296333 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20164s055lbl.pdf', 'application_number': 20164, 'submission_type': 'SUPPL ', 'submission_number': 55} |
12,289 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not... | custom-source | 2025-02-12T13:46:57.403633 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020164s085lbl.pdf', 'application_number': 20164, 'submission_type': 'SUPPL ', 'submission_number': 85} |
12,288 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not inc... | custom-source | 2025-02-12T13:46:57.782709 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020164s080lbl.pdf', 'application_number': 20164, 'submission_type': 'SUPPL ', 'submission_number': 80} |
12,290 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not... | custom-source | 2025-02-12T13:46:57.854723 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020164s093lbl.pdf', 'application_number': 20164, 'submission_type': 'SUPPL ', 'submission_number': 93} |
12,291 | NDA 20-165/S-024
Page 3
Drug Facts panel:
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDA 20-165/S-024
Page 4
User’s Guide: (MRI warning appears on pages 5 and 10)
This label may not be the latest approved... | custom-source | 2025-02-12T13:46:57.864563 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020165s024lbl.pdf', 'application_number': 20165, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,292 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:46:58.122084 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020165Orig1s029lbl.pdf', 'application_number': 20165, 'submission_type': 'SUPPL ', 'submission_number': 29} |
12,293 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:46:58.349071 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s034lbl.pdf', 'application_number': 20165, 'submission_type': 'SUPPL ', 'submission_number': 34} |
12,295 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:46:58.494833 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20165Orig1s038lbl.pdf', 'application_number': 20165, 'submission_type': 'SUPPL ', 'submission_number': 38} |
12,294 | Reference ID: 3829782
Reference ID: 3830548
(b) (4)
(b) (4)
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID: 3829782
Reference ID: 3830548
(b) (4)
(b) (4)
This label may not be the latest approved by FDA.
For current label... | custom-source | 2025-02-12T13:46:59.118164 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020165Orig1s036lbl.pdf', 'application_number': 20165, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,296 | Standard Magnesium,
Low Magnesium,
Low Magnesium,
Standard Calcium
Standard Calcium
Low Calcium
Main Bag Contents
Dextrose Hydrous,
1.52
2.56
4.36
1.54
2.56
4.36
1.54
2.56
4.36
USP (C6H12O6· H2
O)
g
g
g
g
g
g
g
g
g
Sodium Chloride,USP
581
581
581
552
552
552
552
552
552
(NaCl)
mg... | custom-source | 2025-02-12T13:46:59.418334 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018883s044,020171s026lbl.pdf', 'application_number': 20171, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,297 | Figure 1: DELFLEX® Conventional with stay•safe® Exchange Set– 2.5% Dextrose,
Low Mg/Low Ca
Figure 2: DELFLEX® Conventional with stay•safe® Exchange Set – 4.25% Dextrose,
Low Mg/Standard Ca
Reference ID: 3683488
This label may not be the latest approved by FDA.
For current labeling information, please ... | custom-source | 2025-02-12T13:46:59.451768 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018883Orig1s057,020171Orig1s039lbl.pdf', 'application_number': 20171, 'submission_type': 'SUPPL ', 'submission_number': 39} |
12,298 | NDA 20-180/S-026
Page 3
PROSCAR®
(FINASTERIDE)
TABLETS
DESCRIPTION
PROSCAR* (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II
5 -reductase, an intracellular enzyme that converts the androgen testosterone into 5 -dihydrotestosterone
(DHT).
Finasteride is 4-azaandrost... | custom-source | 2025-02-12T13:46:59.643478 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020180s026lbl.pdf', 'application_number': 20180, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,299 |
Merck & Co., Inc.
PROSCAR®
(FINASTERIDE)
TABLETS
DESCRIPTION
PROSCAR* (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II
5α-reductase,
an
intracellular
enzyme
that
converts
the
... | custom-source | 2025-02-12T13:46:59.725499 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020180s037lbl.pdf', 'application_number': 20180, 'submission_type': 'SUPPL ', 'submission_number': 37} |
12,300 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PROSCAR safely and effectively. See full prescribing information
for PROSCAR.
PROSCAR® (finasteride) Tablets
Initial... | custom-source | 2025-02-12T13:46:59.889245 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020180s040s041s042lbl.pdf', 'application_number': 20180, 'submission_type': 'SUPPL ', 'submission_number': 41} |
12,301 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PROSCAR safely and effectively. See full prescribing information
for PROSCAR.
PROSCAR® (finasteride) Tablets
Initial U.S... | custom-source | 2025-02-12T13:46:59.980674 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020180s044lbl.pdf', 'application_number': 20180, 'submission_type': 'SUPPL ', 'submission_number': 44} |
12,302 | custom-source | 2025-02-12T13:47:00.075652 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182s6_Carnitor_prntlbl.pdf', 'application_number': 20182, 'submission_type': 'SUPPL ', 'submission_number': 6} | |
12,304 | Reference ID: 3296493
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID: 3296493
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Reference ID... | custom-source | 2025-02-12T13:47:00.126607 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017512s113,020163s020,020183s019lbl.pdf', 'application_number': 20183, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,305 |
DIANEAL Peritoneal Dialysis Solution
For intraperitoneal administration only
DIANEA... | custom-source | 2025-02-12T13:47:00.255158 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017512s122,020163s027,020183s026lbl.pdf', 'application_number': 20183, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,303 | NDA 18-948/S-022
NDA 19-257/S-010
NDA 20-182/S-008
Page 3
CARNITOR
®
(levocarnitine)
CARNITOR® (levocarnitine) Tablets (330 mg)
CARNITOR® (levocarnitine) Oral Solution (1 g per 10 mL multidose)
For oral use only. Not for parenteral use.
DESCRIPTION
CARNITOR® (levocarnitine) is a carrier molecule in th... | custom-source | 2025-02-12T13:47:00.361897 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf', 'application_number': 20182, 'submission_type': 'SUPPL ', 'submission_number': 8} |
12,306 | NDA 20-184/S-011
Page 3
ACEON®
(perindopril erbumine) Tablets
500063/500064 Rev May 2005
USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and
even death to the developing fetus. When pregnancy is detected, ACEON® Tablets should be
discontinued ... | custom-source | 2025-02-12T13:47:00.479789 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020184s011lbl.pdf', 'application_number': 20184, 'submission_type': 'SUPPL ', 'submission_number': 11} |
12,307 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use ACEON® safely and effectively. See full prescribin... | custom-source | 2025-02-12T13:47:00.584223 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020184s017lbl.pdf', 'application_number': 20184, 'submission_type': 'SUPPL ', 'submission_number': 17} |
12,308 |
HIG... | custom-source | 2025-02-12T13:47:00.772911 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020184s019lbl.pdf', 'application_number': 20184, 'submission_type': 'SUPPL ', 'submission_number': 19} |
12,309 |
... | custom-source | 2025-02-12T13:47:00.916850 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020186s023lbl.pdf', 'application_number': 20186, 'submission_type': 'SUPPL ', 'submission_number': 23} |
12,311 |
5
10
15
20
25
30
35
40
45
50
NDA 020189/S-027
FDA Approved Labeling Text dated 8/27/2012
Page 1
1
FELBATOL® (felbamate)
2
Tablets 400 mg and 600 mg, Oral Suspension 600 mg/5 mL
3
IN-00431-18
Rev. 7/11
4
Before Prescribing Felbatol® (felbamate), the physician... | custom-source | 2025-02-12T13:47:01.078856 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027lbl.pdf', 'application_number': 20189, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,310 | 1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
FELBATOL® (felbamate)
Tablets 400 mg and 600 mg, Oral Suspension 600 mg/5 mL
Before... | custom-source | 2025-02-12T13:47:01.155722 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020189s022lbl.pdf', 'application_number': 20189, 'submission_type': 'SUPPL ', 'submission_number': 22} |
12,312 |
ELMIRON®-100 mg
(pentosan polysulfate sodium) Capsules
Prescribing Information
DESCRIPTION
Pentosan polysulfate sodium is a semi-synthetically produced heparin-like
macromolecular carbohydrate derivative, which chemically and structurally
resembles g... | custom-source | 2025-02-12T13:47:01.197923 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s009lbl.pdf', 'application_number': 20193, 'submission_type': 'SUPPL ', 'submission_number': 9} |
12,313 | NDA 20-198/S-017
Page 2
ADALAT® CC
(nifedipine)
Extended Release Tablets
For Oral Use
08918360, R.0
10/04
DESCRIPTION
ADALAT® CC is an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-
pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dime... | custom-source | 2025-02-12T13:47:01.341737 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20198s017lbl.pdf', 'application_number': 20198, 'submission_type': 'SUPPL ', 'submission_number': 17} |
12,314 | HIVID® (zalcitabine) Tablets - PACKAGE INSERT
1
HIVID®
(zalcitabine)
TABLETS
WARNING:
THE USE OF HIVID HAS BEEN ASSOCIATED WITH SIGNIFICANT CLINICAL
ADVERSE REACTIONS, SOME OF WHICH ARE POTENTIALLY FATAL. HIVID CAN
CAUSE SEVERE PERIPHERAL NEUROPATHY AND BECAUSE OF THIS SHOULD BE
USED WITH EXTREME C... | custom-source | 2025-02-12T13:47:01.509396 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s014lbl.pdf', 'application_number': 20199, 'submission_type': 'SUPPL ', 'submission_number': 14} |
12,315 |
EN-1227xxxx
Page 1 of 7
DOBUTamine
in 5% Dextrose Injection, USP
Flexible Plastic Container Rx only
DESCRIPTION
Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of
dobutamine hydrochloride and dextrose in water for injec... | custom-source | 2025-02-12T13:47:01.533893 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020201s036lbl.pdf', 'application_number': 20201, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,316 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:47:01.584594 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020204s021lbl.pdf', 'application_number': 20204, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,317 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:47:01.664567 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020204Orig1s048Lbl.pdf', 'application_number': 20204, 'submission_type': 'SUPPL ', 'submission_number': 48} |
12,319 | ZINECARD (dexrazoxane for injection)
US Package Insert
FDA Approved Labeling for S-006
1(10)
1
Zinecard®
2
dexrazoxane for injection
3
4
5
DESCRIPTION
6
7
ZINECARD® (dexrazoxane for injection) is a sterile, pyrogen-free lyophilizate intended for
8
intravenous administration. It is a cardioprotective agent for use in c... | custom-source | 2025-02-12T13:47:01.804113 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20212se7-004,005,006lbl.pdf', 'application_number': 20212, 'submission_type': 'SUPPL ', 'submission_number': 5} |
12,318 | PRESCRIBING INFORMATION
1
ALKERAN®
2
(melphalan hydrochloride)
3
for Injection
4
5
WARNING
6
Melphalan should be administered under the supervision of a qualified physician experienced in
7
the use of cancer chemotherapeutic agents. Severe bone marrow suppression with resulting
8
infection or bleeding may occur. Contro... | custom-source | 2025-02-12T13:47:01.893953 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20207slr007_alkeran_lbl.pdf', 'application_number': 20207, 'submission_type': 'SUPPL ', 'submission_number': 7} |
12,320 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZINECARD safely and effectively. See full prescribing information for
ZINECARD.
ZINECARD® (dexrazoxane) for injection
Initial U.S. Approval: 1995
---------------------------INDICATIONS AND USAGE-... | custom-source | 2025-02-12T13:47:01.953410 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020212s017lbl.pdf', 'application_number': 20212, 'submission_type': 'SUPPL ', 'submission_number': 17} |
12,321 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ZEMURON safely and effective... | custom-source | 2025-02-12T13:47:02.179601 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020214s030lbl.pdf', 'application_number': 20214, 'submission_type': 'SUPPL ', 'submission_number': 30} |
12,322 | NDA 20-216/S-054
NDA 10-402/S-048
Page 3
NOTE: PATIENT INFORMATION LEAFLET ATTACHED.
Premarin(conjugated estrogens)
Vaginal Cream in a nonliquefying base
℞ only
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnost... | custom-source | 2025-02-12T13:47:02.332175 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010402s048,020216s054lbl.pdf', 'application_number': 20216, 'submission_type': 'SUPPL ', 'submission_number': 54} |
12,323 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use PREMARIN Vagin... | custom-source | 2025-02-12T13:47:02.574360 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020216s060lbl.pdf', 'application_number': 20216, 'submission_type': 'SUPPL ', 'submission_number': 60} |
12,324 |
&;
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do... | custom-source | 2025-02-12T13:47:02.720257 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf', 'application_number': 20216, 'submission_type': 'SUPPL ', 'submission_number': 73} |
12,325 |
&;
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do... | custom-source | 2025-02-12T13:47:02.749493 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020216s073s074s075lbl.pdf', 'application_number': 20216, 'submission_type': 'SUPPL ', 'submission_number': 75} |
12,326 |
______________________________________________________________________________________________________________________________
HIGHLIGH... | custom-source | 2025-02-12T13:47:02.913308 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020220s033lbl.pdf', 'application_number': 20220, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,327 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ULTRAVIST Injection safely and effectively. See full prescribing
information for ULTRAVIST Injection.
ULTRAVIST (iopromide) Injection, for intravenous or intra-arterial use
Initial U.S. Approval: 1995
WARNING:... | custom-source | 2025-02-12T13:47:03.094840 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020220s036lbl.pdf', 'application_number': 20220, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,329 |
NDA 20-221/S-024
Page 3
ETHYOL®
(amifostine) for Injection
Description
Clinical Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Rx only
DESCRIPTION
ETHYOL (amifostin... | custom-source | 2025-02-12T13:47:03.190660 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020221s024lbl.pdf', 'application_number': 20221, 'submission_type': 'SUPPL ', 'submission_number': 24} |
12,330 |
Colestid®
Flavored Colestid®
colestipol hydrochloride for oral suspension
DESCRIPTION
COLESTID Granules and FLAVORED COLESTID Granules contain colestipol
hydrochloride, which is a lipi... | custom-source | 2025-02-12T13:47:03.283281 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017563s023,020222s005lbl.pdf', 'application_number': 20222, 'submission_type': 'SUPPL ', 'submission_number': 5} |
12,328 |
___... | custom-source | 2025-02-12T13:47:03.721894 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020220s041,021425s024lbl.pdf', 'application_number': 20220, 'submission_type': 'SUPPL ', 'submission_number': 41} |
12,334 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:47:03.830153 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020231Orig1s075lbl.pdf', 'application_number': 20231, 'submission_type': 'SUPPL ', 'submission_number': 75} |
12,336 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:47:04.155014 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1996/020234lbl.pdf', 'application_number': 20234, 'submission_type': 'ORIG ', 'submission_number': 1} |
12,335 |
Fioricet® with Codeine C-III
(Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate) Capsules
Rx only
184178-3
WAR... | custom-source | 2025-02-12T13:47:04.263326 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s035lbl.pdf', 'application_number': 20232, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,337 | Page 3
Tegretol®
carbamazepine USP
Chewable Tablets of 100 mg - red-speckled, pink
Tablets of 200 mg – pink
Suspension of 100 mg/5 mL
Tegretol®-XR
(carbamazepine extended-release tablets)
100 mg, 200 mg, 400 mg
Rx only
Prescribing Information
WARNING
APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN... | custom-source | 2025-02-12T13:47:04.741016 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016608s096,018281s044,018927s035,020234s025REVISED_LABEL.pdf', 'application_number': 20234, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,338 |
NDA 016608/S-097
NDA 018281/S-045
NDA 018927/S-038
NDA 020234/S-026
FDA Approved Labeling Text dated 8/28/2015
Page 1
Tegretol®
carbamazepine USP
Chewable Tablets of 100 mg - red... | custom-source | 2025-02-12T13:47:06.609250 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016608s097,018281s045,018927s038,020234s026lbl.pdf', 'application_number': 20234, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,332 |
Labels for NDA 20231
Supplement S-072
Reference ID: 3523812
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Total Adv Clean Between Paste 5.8oz Carton For FDA approval
Date: 05/09/2014
Part# Front: P9888149
Morristown, TN
Ver... | custom-source | 2025-02-12T13:47:06.654668 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020231Orig1s072, 020231Orig1s073lbl.pdf', 'application_number': 20231, 'submission_type': 'SUPPL ', 'submission_number': 72} |
12,339 | Page 3
Tegretol®
carbamazepine USP
Chewable Tablets of 100 mg - red-speckled, pink
Tablets of 200 mg – pink
Suspension of 100 mg/5 mL
Tegretol®-XR
(carbamazepine extended-release tablets)
100 mg, 200 mg, 400 mg
Rx only
Prescribing Information
WARNING
SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 A... | custom-source | 2025-02-12T13:47:06.745746 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020234s028lbl.pdf', 'application_number': 20234, 'submission_type': 'SUPPL ', 'submission_number': 28} |
12,340 |
company logo
Tegretol®
carbamazepine USP
Chewable Tablets of 100 mg - red-speckled, pink
Tablets of 200 mg – pink
Suspension of 100 mg/5 mL
Tegretol®-XR
(carbamazepine extended-release tablets)
100 mg, 200 mg, 400 mg
Rx only
Prescribing Information
WARNINGS
SERIOUS DERMATOLOGIC REACTIONS AND... | custom-source | 2025-02-12T13:47:07.122968 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf', 'application_number': 20234, 'submission_type': 'SUPPL ', 'submission_number': 31} |
12,341 |
company logo
Tegretol®
carbamazepine USP
Chewable Tablets of 100 mg - red-speckled, pink
Tablets of 200 mg – pink
Suspension of 100 mg/5 mL
Tegretol®-XR
(carbamazepine extended-release tablets)
100 mg, 200 mg, 400 mg
Rx only
Prescribing Information
WARNINGS
SERIOUS DERMATOLOGIC REACTIONS AND... | custom-source | 2025-02-12T13:47:07.295484 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/016608s100s102,018281s049s050,018927s041s042,020234s031s033lbl.pdf', 'application_number': 20234, 'submission_type': 'SUPPL ', 'submission_number': 33} |
12,342 |
NDA 016608/S-107
NDA 018281/S-055
NDA 018927/S-048
NDA 020234/S-040
FDA Approved Labeling Text dated 12/11/2012
Page 1 company logo
Tegretol®
carbamazepine USP
Chewable Tablets of 100 mg - red-speckled, pink
Tablets of 200 mg – pink
Suspension of 100 mg/5 mL
Tegretol®-XR
(carbamazepine extended... | custom-source | 2025-02-12T13:47:07.360160 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016608s107,018281s055,018927s048,020234s040lbl.pdf', 'application_number': 20234, 'submission_type': 'SUPPL ', 'submission_number': 40} |
12,333 |
Labels for NDA 20231
Supplement S-072
Reference ID: 3523812
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Total Adv Clean Between Paste 5.8oz Carton For FDA approval
Date: 05/09/2014
Part# Front: P9888149
Morristown, TN
Ver... | custom-source | 2025-02-12T13:47:09.022057 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020231Orig1s072, 020231Orig1s073lbl.pdf', 'application_number': 20231, 'submission_type': 'SUPPL ', 'submission_number': 73} |
12,343 | NDA 21-216, NDA 20-235/S-015, NDA 20-882/S-002, NDA 21-129/S-005
Page 1
FDA approved labeling text (dated 10/12/00)
Neurontin® (gabapentin) capsules,
Neurontin® (gabapentin) tablets
Neurontin® (gabapentin) oral solution
DESCRIPTION
Neurontin® (gabapentin) capsules, Neurontin® (gabapentin) tablets, and Neurontin®
(gabap... | custom-source | 2025-02-12T13:47:09.047676 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf', 'application_number': 20235, 'submission_type': 'SUPPL ', 'submission_number': 15} |
12,344 | NDA 20-235/S-029; NDA 20-882/S-015; NDA 21-129/S-016
FDA Approved Labeling Text dated February 2005
Page 1 of 29
Neurontin® (gabapentin) Capsules
Neurontin® (gabapentin) Tablets
Neurontin®(gabapentin) Oral Solution
DESCRIPTION
Neurontin® (gabapentin) Capsules, Neurontin® (gabapentin) Tablets, and Neu... | custom-source | 2025-02-12T13:47:09.250463 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s016lbl.pdf', 'application_number': 20235, 'submission_type': 'SUPPL ', 'submission_number': 29} |
12,346 |
Neurontin® (gabapentin) Capsules
Neurontin® (gabapentin) Tablets
Neurontin® (gabapentin) Oral Solution
DESCRIPTION
Neurontin® (gabapentin) Capsules, Neurontin (gabapentin) Tablets, and Neurontin (gabapentin)
Oral Solution are supplied as imprinted hard shell capsules containing 100 mg,
3... | custom-source | 2025-02-12T13:47:09.360180 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020235s043lbl.pdf', 'application_number': 20235, 'submission_type': 'SUPPL ', 'submission_number': 43} |
12,347 |
NDA 020235/S-054, S-055, S-056
NDA 020882/S-038, S-039, S-040
NDA 021129/S-035, S-036, S-037
FDA Approved Labeling Text dated 05/01/2013
Page 1 of 37
Neurontin® (gabapentin) Capsules
Neurontin® (gabapentin) Tablets
Neurontin® (gabapentin) Oral S... | custom-source | 2025-02-12T13:47:09.586971 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf', 'application_number': 20235, 'submission_type': 'SUPPL ', 'submission_number': 56} |
12,345 |
NDA 020235/S-036; NDA 020882/S-022; NDA 021129/S-022
FDA Approved Labeling Text dated 03/01/2011
Page 1
Neurontin® (gabapentin) Capsules
Neurontin® (gabapentin) Tablets
Neurontin® (gabapentin) Oral Solution
DESCRIPTION
Neurontin® (gabapentin) Capsules, Neurontin (gabapentin) Tablets... | custom-source | 2025-02-12T13:47:09.590244 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s036,020882s022,021129s022lbl.pdf', 'application_number': 20235, 'submission_type': 'SUPPL ', 'submission_number': 36} |
12,348 |
HIGHLIGHTS OF PR... | custom-source | 2025-02-12T13:47:09.766309 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s060,020882s043,021129s042lbl.pdf', 'application_number': 20235, 'submission_type': 'SUPPL ', 'submission_number': 60} |
12,349 | 1
PRODUCT INFORMATION
SEREVENT®
(salmeterol xinafoate)
Inhalation Aerosol
Bronchodilator Aerosol
For Oral Inhalation Only
WARNING: Data from a large placebo-controlled US study that compared the safety of
salmeterol (SEREVENT Inhalation Aerosol) or placebo added to usual asthma therapy showed a
small but significant in... | custom-source | 2025-02-12T13:47:09.872563 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20236slr028_serevent_lbl.pdf', 'application_number': 20236, 'submission_type': 'SUPPL ', 'submission_number': 28} |
12,350 |
3
SALAGEN
®
Tablets
(pilocarpine hydrochloride)
DESCRIPTION: SALAGEN
®
Tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral
use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder, which is
soluble in water and alcohol and virtually insolub... | custom-source | 2025-02-12T13:47:10.062316 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20237s8s9lbl.pdf', 'application_number': 20237, 'submission_type': 'SUPPL ', 'submission_number': 9} |
12,351 | NDA 20-237/S012
Page 3
SALAGEN
®
Tablets
(pilocarpine hydrochloride)
DESCRIPTION: SALAGEN
®
Tablets contain pilocarpine hydrochloride, a cholinergic agonist for
oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or
powder which is soluble in water and alcohol an... | custom-source | 2025-02-12T13:47:10.120511 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020237s012lbl.pdf', 'application_number': 20237, 'submission_type': 'SUPPL ', 'submission_number': 12} |
12,352 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
| custom-source | 2025-02-12T13:47:10.199738 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020238s013lbl.pdf', 'application_number': 20238, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,353 | 19apr2004
KYTRIL
(granisetron hydrochloride)
Injection
Rx only
DESCRIPTION
KYTRIL (granisetron hydrochloride) Injection is an antinauseant and antiemetic agent.
Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-
3-carboxamide hydrochloride with a molecular weight of 348.9 (... | custom-source | 2025-02-12T13:47:10.250453 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20239s015lbl.pdf', 'application_number': 20239, 'submission_type': 'SUPPL ', 'submission_number': 15} |
12,354 | 1
1
KYTRIL®
2
(granisetron hydrochloride)
3
INJECTION
4
Rx only
5
DESCRIPTION
6
KYTRIL (granisetron hydrochloride) Injection is an antinauseant and antiemetic agent.
7
Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-
8
3-carboxamide hydrochloride with a molecular w... | custom-source | 2025-02-12T13:47:10.344258 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020239s018lbl.pdf', 'application_number': 20239, 'submission_type': 'SUPPL ', 'submission_number': 18} |
12,356 |
______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:47:10.538210 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020239s023lbl.pdf', 'application_number': 20239, 'submission_type': 'SUPPL ', 'submission_number': 23} |
12,355 |
Roche logo
KYTRIL®
(granisetron hydrochloride)
INJECTION
Rx only
DESCRIPTION
KYTRIL (granisetron hydrochloride) Injection is an antinauseant and antiemetic agent.
Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole
3-carboxamide hydrochloride with a molecular wei... | custom-source | 2025-02-12T13:47:10.630189 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf', 'application_number': 20239, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,357 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
This label may not be the latest approved by FDA.
For cu... | custom-source | 2025-02-12T13:47:10.752101 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20241s2lbl.pdf', 'application_number': 20241, 'submission_type': 'SUPPL ', 'submission_number': 2} |
12,358 | 1
PRESCRIBING INFORMATION
1
LAMICTAL®
2
(lamotrigine)
3
Tablets
4
5
LAMICTAL®
6
(lamotrigine)
7
Chewable Dispersible Tablets
8
9
SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION
10
OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF
11
LAMICTAL. THE INCIDENCE OF THESE... | custom-source | 2025-02-12T13:47:10.946805 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf', 'application_number': 20241, 'submission_type': 'SUPPL ', 'submission_number': 10} |
12,359 | 1
PRESCRIBING INFORMATION
1
LAMICTAL®
2
(lamotrigine)
3
Tablets
4
5
LAMICTAL®
6
(lamotrigine)
7
Chewable Dispersible Tablets
8
9
SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION
10
OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF
11
LAMICTAL. THE INCIDENCE OF THESE... | custom-source | 2025-02-12T13:47:11.348361 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf', 'application_number': 20241, 'submission_type': 'SUPPL ', 'submission_number': 21} |
12,360 | 1
PRESCRIBING INFORMATION
1
LAMICTAL®
2
(lamotrigine)
3
Tablets
4
5
LAMICTAL®
6
(lamotrigine)
7
Chewable Dispersible Tablets
8
9
SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION
10
OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF
11
LAMICTAL. THE INCIDENCE OF THESE... | custom-source | 2025-02-12T13:47:11.400932 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf', 'application_number': 20241, 'submission_type': 'SUPPL ', 'submission_number': 26} |
12,361 | 1
PRESCRIBING INFORMATION
1
LAMICTAL®
2
(lamotrigine)
3
Tablets
4
5
LAMICTAL®
6
(lamotrigine)
7
Chewable Dispersible Tablets
8
9
SERIOUS RASHES REQUIRING HOSPITALIZATION AND DISCONTINUATION
10
OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF
11
LAMICTAL. THE INCIDENCE OF THESE... | custom-source | 2025-02-12T13:47:11.502139 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf', 'application_number': 20241, 'submission_type': 'SUPPL ', 'submission_number': 27} |
12,364 |
NDA 020241/S-043 and S-044
NDA 020... | custom-source | 2025-02-12T13:47:12.271228 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf', 'application_number': 20241, 'submission_type': 'SUPPL ', 'submission_number': 43} |
12,362 |
... | custom-source | 2025-02-12T13:47:12.719703 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf', 'application_number': 20241, 'submission_type': 'SUPPL ', 'submission_number': 35} |
12,365 |
... | custom-source | 2025-02-12T13:47:12.986737 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf', 'application_number': 20241, 'submission_type': 'SUPPL ', 'submission_number': 45} |
12,366 |
... | custom-source | 2025-02-12T13:47:13.122189 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf', 'application_number': 20241, 'submission_type': 'SUPPL ', 'submission_number': 51} |
12,367 |
... | custom-source | 2025-02-12T13:47:13.439504 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,022251s017lbl.pdf', 'application_number': 20241, 'submission_type': 'SUPPL ', 'submission_number': 53} |
12,370 |
1
Physician Information
Women who use Depo-Provera Contraceptive Injection may lose significant bone
mineral density. Bone loss is greater with increasing duration of use and may not be
completely reversible.
It is unknown if use of Depo-Provera Contraceptive Injection during adolescence or
early adulthood, a... | custom-source | 2025-02-12T13:47:13.554890 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20246s025lbl.pdf', 'application_number': 20246, 'submission_type': 'SUPPL ', 'submission_number': 25} |
12,368 |
1
Physician Information
Women who use Depo-Provera Contraceptive Injection may lose significant bone
mineral density. Bone loss is greater with increasing duration of use and may not be
completely reversible.
It is unknown if use of Depo-Provera Contraceptive Injection during adolescence or
early adulthood, a... | custom-source | 2025-02-12T13:47:13.657262 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020246s013lbl.pdf', 'application_number': 20246, 'submission_type': 'SUPPL ', 'submission_number': 13} |
12,369 | 5R4606
15
Depo-Provera®
Contraceptive Injection
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually
transmitted diseases.
DESCRIPTION
DEPO-PROVERA Contraceptive Injection contains medroxyprogesterone acetate, a derivative of progesterone, as its active
ingredi... | custom-source | 2025-02-12T13:47:13.698651 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20246scs019_Depo-provera_lbl.pdf', 'application_number': 20246, 'submission_type': 'SUPPL ', 'submission_number': 19} |
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