id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
15,181 |
___________________________... | custom-source | 2025-02-12T13:54:14.847515 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s014lbl.pdf', 'application_number': 21319, 'submission_type': 'SUPPL ', 'submission_number': 14} |
15,179 | NDA 21-319/S-007
Page 3
PRESCRIBING INFORMATION
AVODART™
(dutasteride)
Soft Gelatin Capsules
DESCRIPTION
AVODART (dutasteride) is a synthetic 4-azasteroid compound that is a selective inhibitor of
both the type 1 and type 2 isoforms of steroid 5α-reductase (5AR), an intracellular enzyme that
converts testo... | custom-source | 2025-02-12T13:54:14.932731 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21319s007lbl.pdf', 'application_number': 21319, 'submission_type': 'SUPPL ', 'submission_number': 7} |
15,183 |
... | custom-source | 2025-02-12T13:54:15.250520 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021319s023s025lbl.pdf', 'application_number': 21319, 'submission_type': 'SUPPL ', 'submission_number': 25} |
15,182 | PRESCRIBING INFORMATION
1
2
3
4
5
6
7
8
9
10
11
12
AVODART®
(dutasteride)
Soft Gelatin Capsules
DESCRIPTION
AVODART (dutasteride) is a synthetic 4-azasteroid compound that is a selective inhibitor of
both the type 1 and type 2 isoforms of steroid 5α-reductase (5AR), an intracellular enzyme that
conv... | custom-source | 2025-02-12T13:54:15.461041 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021319s015lbl.pdf', 'application_number': 21319, 'submission_type': 'SUPPL ', 'submission_number': 15} |
15,185 |
... | custom-source | 2025-02-12T13:54:15.464117 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf', 'application_number': 21319, 'submission_type': 'SUPPL ', 'submission_number': 29} |
15,184 |
... | custom-source | 2025-02-12T13:54:15.527075 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021319s028s029lbl.pdf', 'application_number': 21319, 'submission_type': 'SUPPL ', 'submission_number': 28} |
15,186 |
Page 1 of 2
HOSPITAL PHARMACY’S ACCEPTANCE OF
RESPONSIBILITIES
Plenaxis® PLUS Program
For safety reasons, the marketing of Plenaxis® is restricted. The Plenaxis® PLUS Program
(Plenaxis® User Safety Program) ensures hospital pharmacies understand that only physicians who
are enrolled with PRAECIS PHAR... | custom-source | 2025-02-12T13:54:15.657577 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021320s002lbl.pdf', 'application_number': 21320, 'submission_type': 'SUPPL ', 'submission_number': 2} |
15,187 | NDA 21-321
Page 6
EXTRANEAL
(icodextrin) Peritoneal Dialysis Solution
DESCRIPTION
EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a peritoneal dialysis solution containing the
colloid osmotic agent icodextrin. Icodextrin is a starch-derived, water-soluble glucose polymer linked
by alpha (1-4) and ... | custom-source | 2025-02-12T13:54:15.886149 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21321_Extraneal_lbl.pdf', 'application_number': 21321, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,188 |
NDA 21321
S-020/S-021
Page 6
EXTRANEAL
(icodextrin) Peritoneal Dialysis Solution
Dangerous Drug-Device Interaction
Only use glucose-specific monitors and test strips to measure blood glucose levels in patients
using Extraneal (icodextrin) Peritoneal Dialysis Solution. Blood glu... | custom-source | 2025-02-12T13:54:16.048331 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021321s020s021lbl.pdf', 'application_number': 21321, 'submission_type': 'SUPPL ', 'submission_number': 20} |
15,190 | NDA 21-323 Attachment Approved Labeling
Page 1
LEXAPRO™
(escitalopram oxalate)
DESCRIPTION
LEXAPRO™ (escitalopram oxalate) is an orally administered selective serotonin reuptake
inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single i... | custom-source | 2025-02-12T13:54:16.132431 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21323lbl.pdf', 'application_number': 21323, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,189 |
... | custom-source | 2025-02-12T13:54:16.202763 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021321s032lbl.pdf', 'application_number': 21321, 'submission_type': 'SUPPL ', 'submission_number': 32} |
15,191 |
1
LEXAPRO™
(escitalopram oxalate)
TABLETS/ORAL SOLUTION
Rx Only
DESCRIPTION
LEXAPRO™ (escitalopram oxalate) is an orally administered selective serotonin reuptake
inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic
phthalane
derivative
cit... | custom-source | 2025-02-12T13:54:16.300013 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21323se1-003,se8-007,21365se8-001,se1-004_lexapro_lbl.pdf', 'application_number': 21323, 'submission_type': 'SUPPL ', 'submission_number': 7} |
15,192 | 1
Lexapro®
(escitalopram oxalate)
TABLETS/ORAL SOLUTION
Rx Only
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior
(suicidality) in children, adolescents, and young adults in short-term studies of major depressive
disorder (MD... | custom-source | 2025-02-12T13:54:16.551655 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021323s025lbl.pdf', 'application_number': 21323, 'submission_type': 'SUPPL ', 'submission_number': 25} |
15,193 |
HIGHLIGHTS OF PRESCRIBING INFORMATIO... | custom-source | 2025-02-12T13:54:16.805482 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s033,021365s024lbl.pdf', 'application_number': 21323, 'submission_type': 'SUPPL ', 'submission_number': 33} |
15,195 |
30029-XX
Entocort® EC
(budesonide) Capsules
Rx only
DESCRIPTION
Budesonide, the active ingredient of ENTOCORT® EC capsules,
is a synthetic corticosteroid. It is designated chemically as (RS)
11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic
16,17-acetal with butyraldehyde. Bud... | custom-source | 2025-02-12T13:54:16.828531 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021324s008lbl.pdf', 'application_number': 21324, 'submission_type': 'SUPPL ', 'submission_number': 8} |
15,196 |
______________________________________________________________________________
... | custom-source | 2025-02-12T13:54:16.990803 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021324s009lbl.pdf', 'application_number': 21324, 'submission_type': 'SUPPL ', 'submission_number': 9} |
15,197 |
... | custom-source | 2025-02-12T13:54:17.311977 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021324s012s013lbl.pdf', 'application_number': 21324, 'submission_type': 'SUPPL ', 'submission_number': 12} |
15,194 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do ... | custom-source | 2025-02-12T13:54:17.508972 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021323s035,021365s025lbl.pdf', 'application_number': 21323, 'submission_type': 'SUPPL ', 'submission_number': 35} |
15,198 | Warnings
If you are pregnant or breast-feeding, only use this medicine
on the advice of your health care provider. Smoking can
seriously harm your child. Try to stop smoking without using
any nicotine replacement medicine. This medicine is believed to
be safer than smoking. However, the risks to your child from this... | custom-source | 2025-02-12T13:54:17.620297 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21330scf002_committ_lbl.pdf', 'application_number': 21330, 'submission_type': 'SUPPL ', 'submission_number': 2} |
15,200 | NDA21-330/S-005
Page 3
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDA21-330/S-005
Page 4
This label may not be the latest approved by FDA.
For current labeling information, please ... | custom-source | 2025-02-12T13:54:17.722977 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021330s005lbl.pdf', 'application_number': 21330, 'submission_type': 'SUPPL ', 'submission_number': 5} |
15,202 | 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 | 2025-02-12T13:54:18.115014 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021330Orig1s016lbl.pdf', 'application_number': 21330, 'submission_type': 'SUPPL ', 'submission_number': 16} |
15,203 | Reference ID: 3757647
(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: 3757647
(b) (4)
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda... | custom-source | 2025-02-12T13:54:18.833559 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330Orig1s018lbl.pdf', 'application_number': 21330, 'submission_type': 'SUPPL ', 'submission_number': 18} |
15,205 |
... | custom-source | 2025-02-12T13:54:19.486412 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf', 'application_number': 21332, 'submission_type': 'SUPPL ', 'submission_number': 7} |
15,207 |
Desmopressin Acetate
Nasal Spray, 10 mcg per 0.1 mL
Rx only
DESCRIPTION
Desmopressin Acetate Nasal Spray is a synthetic analogue of the natural pituitary hormone 8
argin... | custom-source | 2025-02-12T13:54:19.926371 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021333s007lbl.pdf', 'application_number': 21333, 'submission_type': 'SUPPL ', 'submission_number': 7} |
15,208 | custom-source | 2025-02-12T13:54:20.498425 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S010_Avelox_prntlbl.pdf', 'application_number': 21334, 'submission_type': 'ORIG ', 'submission_number': 1} | |
15,206 |
... | custom-source | 2025-02-12T13:54:20.521628 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s023lbl.pdf', 'application_number': 21332, 'submission_type': 'SUPPL ', 'submission_number': 23} |
15,209 | Novartis Pharmaceuticals Corporation
East Hanover, New Jersey
Revised (5/9/01 9:03 AM)
1
GLEEVEC™ (imatinib mesylate) Capsules
2
NDA 21-335
3
DRAFT Package Insert
4
Property of Novartis Pharma AG
5
Confidential
6
May not be used, divulged, published or otherwise disclosed
7
without the consent of Novartis Pharma AG
8
T... | custom-source | 2025-02-12T13:54:20.774560 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21335lbl.pdf', 'application_number': 21335, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,210 | EMSAM®
(SELEGILINE TRANSDERMAL SYSTEM)
CONTINUOUS DELIVERY FOR ONCE-DAILY APPLICATION
Rx only
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior
(suicidality) in children, adolescents and young adults in short-term studies of majo... | custom-source | 2025-02-12T13:54:21.085151 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021336s002lbl.pdf', 'application_number': 21336, 'submission_type': 'SUPPL ', 'submission_number': 2} |
15,212 |
Str
uctu
ra
l
F
ormu
la
Company logo
9709709
123A-07/09
515055Z
INVANZ
®
(ERTAPENEM FOR INJECTION)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of INVANZ and
other antibacterial drugs, INVAN... | custom-source | 2025-02-12T13:54:21.845536 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021337s033lbl.pdf', 'application_number': 21337, 'submission_type': 'SUPPL ', 'submission_number': 33} |
15,211 |
company logo
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INVANZ safely and effectively. See full prescrib... | custom-source | 2025-02-12T13:54:21.890756 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021337s031lbl.pdf', 'application_number': 21337, 'submission_type': 'SUPPL ', 'submission_number': 31} |
15,199 | ®
STOP SMOKING AID
nicotine polacrilex lozenge, 2mg
MINT FLAVOR
MINT FLAVOR
Directions:
Place the lozenge in your mouth and allow the lozenge to slowly dissolve.
Occasionally move the lozenge from one side to your mouth to the other until
completely dissolved (about 20 – 30 minutes). Do not eat or drink 15
minutes ... | custom-source | 2025-02-12T13:54:22.692926 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021330s003lbl.pdf', 'application_number': 21330, 'submission_type': 'SUPPL ', 'submission_number': 3} |
15,213 |
s
tru
ctur
al
fo
rmul
a
company logo
9709712
016A-02/10
515094Z
INVANZ
®
(ERTAPENEM FOR INJECTION)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of INVANZ and
other antibacterial drugs, INVANZ... | custom-source | 2025-02-12T13:54:22.814199 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021337s034lbl.pdf', 'application_number': 21337, 'submission_type': 'SUPPL ', 'submission_number': 34} |
15,214 |
company logo
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INVANZ safely and effectively. See full prescribing information for
INVANZ.
IN... | custom-source | 2025-02-12T13:54:22.823907 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021337s037lbl.pdf', 'application_number': 21337, 'submission_type': 'SUPPL ', 'submission_number': 37} |
15,215 |
company logo
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INVANZ ... | custom-source | 2025-02-12T13:54:23.131522 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021337s038lbl.pdf', 'application_number': 21337, 'submission_type': 'SUPPL ', 'submission_number': 38} |
15,216 |
... | custom-source | 2025-02-12T13:54:23.383522 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021337s042lbl.pdf', 'application_number': 21337, 'submission_type': 'SUPPL ', 'submission_number': 42} |
15,217 |
Page 1
IONSYS™
CII
(fentanyl iontophoretic transdermal system)
40 mcg*/activation
Patient-activated
* Equals to 44.4 mcg fentanyl HCl
IONSYS™ should only be used for the treatment of hospitalized patients.
Treatment with IONSYS™ should be discontinued before patients are dischar... | custom-source | 2025-02-12T13:54:23.702443 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021338lbl.pdf', 'application_number': 21338, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,218 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information n... | custom-source | 2025-02-12T13:54:23.777629 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021338s005lbl.pdf', 'application_number': 21338, 'submission_type': 'SUPPL ', 'submission_number': 5} |
15,219 | NDA 21-341
Page 4
DESCRIPTION
BEXTRA (valdecoxib tablets) is chemically designated as 4-(5-methyl-3-phenyl-4-isoxazolyl)
benzenesulfonamide and is a diaryl substituted isoxazole. It has the following chemical structure:
O
N
S
NH2
O
O
CH3
Valdecoxib
The empirical formula for valdecoxib is C16H14N2O3S, and th... | custom-source | 2025-02-12T13:54:23.962119 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21341lbl.pdf', 'application_number': 21341, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,220 | NDA 21-342
Levo-TTM
(Levothyroxine Sodium Tablets, USP)
Rx only
DESCRIPTION
Levo-TTM (levothyroxine sodium tablets, USP) contain synthetic crystalline L-3,3’,5,5’-
tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced
in the human thyroid gland. Levothyroxine (T4) sodiu... | custom-source | 2025-02-12T13:54:24.185439 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21342lbl.pdf', 'application_number': 21342, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,221 |
Levothyroxine Sodium (levothyroxine sodium) Tablet
[MOVA PHARMACEUTICAL CORPORATION]
Rx only
DESCR... | custom-source | 2025-02-12T13:54:24.276812 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021342s008s014lbl.pdf', 'application_number': 21342, 'submission_type': 'SUPPL ', 'submission_number': 8} |
15,222 |
----------
... | custom-source | 2025-02-12T13:54:24.405645 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021342s016lbl.pdf', 'application_number': 21342, 'submission_type': 'SUPPL ', 'submission_number': 16} |
15,223 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:54:24.638065 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021343s019,021379s015,021488s016,021731s012lbl.pdf', 'application_number': 21343, 'submission_type': 'SUPPL ', 'submission_number': 19} |
15,224 |
... | custom-source | 2025-02-12T13:54:24.877518 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021343s027,021379s025,021488s025,021731s023lbl.pdf', 'application_number': 21343, 'submission_type': 'SUPPL ', 'submission_number': 27} |
15,225 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ELIGARD® safely and effectively. See full prescribing information for
ELIGARD®.
ELIGARD® (leuprolide acetate for injectable suspension)
Initial U.S. Approval: 2002
---------------------------RECENT MAJOR CHA... | custom-source | 2025-02-12T13:54:25.096478 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021343s033,021379s033,021488s030,021731s029lbl.pdf', 'application_number': 21343, 'submission_type': 'SUPPL ', 'submission_number': 33} |
15,204 | Reference ID: 3803985
(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: 3803985
(b) (4)
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda... | custom-source | 2025-02-12T13:54:25.368153 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330Orig1s020lbl.pdf', 'application_number': 21330, 'submission_type': 'SUPPL ', 'submission_number': 20} |
15,227 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do no... | custom-source | 2025-02-12T13:54:25.385238 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021344s007s012lbl.pdf', 'application_number': 21344, 'submission_type': 'SUPPL ', 'submission_number': 12} |
15,226 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do no... | custom-source | 2025-02-12T13:54:25.458802 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021344s007s012lbl.pdf', 'application_number': 21344, 'submission_type': 'SUPPL ', 'submission_number': 7} |
15,228 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not ... | custom-source | 2025-02-12T13:54:25.675286 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021344s013lbl.pdf', 'application_number': 21344, 'submission_type': 'SUPPL ', 'submission_number': 13} |
15,230 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not includ... | custom-source | 2025-02-12T13:54:25.878761 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s019s020lbl.pdf', 'application_number': 21344, 'submission_type': 'SUPPL ', 'submission_number': 19} |
15,229 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all th... | custom-source | 2025-02-12T13:54:25.927965 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021344s018lbl.pdf', 'application_number': 21344, 'submission_type': 'SUPPL ', 'submission_number': 18} |
15,231 |
... | custom-source | 2025-02-12T13:54:26.093586 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s026lbl.pdf', 'application_number': 21344, 'submission_type': 'SUPPL ', 'submission_number': 26} |
15,232 |
... | custom-source | 2025-02-12T13:54:26.206508 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021344s029lbl.pdf', 'application_number': 21344, 'submission_type': 'SUPPL ', 'submission_number': 29} |
15,234 | NDA 21-345/S-001
Page 3
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,
heparinoids or fondaparinux sodium for prevention of thromboembolic complicati... | custom-source | 2025-02-12T13:54:26.400507 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21345slr001_arixtra_lbl.pdf', 'application_number': 21345, 'submission_type': 'SUPPL ', 'submission_number': 1} |
15,233 | NDA 21-345
Page 4
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, heparinoids or fondaparinux sodium for prevention
of thromboembolic complicatio... | custom-source | 2025-02-12T13:54:26.503851 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21345lbl.pdf', 'application_number': 21345, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,235 | NDA 21-345/S-002
Page 4
ARIXTRA ®
(fondaparinux sodium) Injection
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,
heparinoids or fondaparinux sodi... | custom-source | 2025-02-12T13:54:26.741549 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21345se1-002_arixtra_lbl.pdf', 'application_number': 21345, 'submission_type': 'SUPPL ', 'submission_number': 2} |
15,236 | NDA 21-345/S-004/S-005
Page 5
ARIXTRA ®
(fondaparinux sodium) Injection
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,
heparinoids or fondaparinux ... | custom-source | 2025-02-12T13:54:26.937696 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21345se1-004,005_arixtra_lbl.pdf', 'application_number': 21345, 'submission_type': 'SUPPL ', 'submission_number': 4} |
15,237 | NDA 21-345/S-004/S-005
Page 5
ARIXTRA ®
(fondaparinux sodium) Injection
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,
heparinoids or fondaparinux ... | custom-source | 2025-02-12T13:54:26.986366 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21345se1-004,005_arixtra_lbl.pdf', 'application_number': 21345, 'submission_type': 'SUPPL ', 'submission_number': 5} |
15,238 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
A... | custom-source | 2025-02-12T13:54:27.134459 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021345s019lbl.pdf', 'application_number': 21345, 'submission_type': 'SUPPL ', 'submission_number': 19} |
15,239 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ARIXTRA safely and effectively. See full ... | custom-source | 2025-02-12T13:54:27.267181 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021345s023lbl.pdf', 'application_number': 21345, 'submission_type': 'SUPPL ', 'submission_number': 23} |
15,241 |
1
JANSSEN
PHARMACEUTICA
PRODUCTS, L.P.
RISPERDAL
(RISPERIDONE)
TABLETS/ORAL SOLUTION
RISPERDAL M-TAB
(RISPERIDONE)
ORALLY DISINTEGRATING TABLETS
Increased Mortality in Elderly Patients with Dementia –Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical
antipsyc... | custom-source | 2025-02-12T13:54:27.519121 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020272s042,020588s030,021444s016,021346s010lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 10} |
15,240 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ARIXTRA sa... | custom-source | 2025-02-12T13:54:27.650853 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021345s025lbl.pdf', 'application_number': 21345, 'submission_type': 'SUPPL ', 'submission_number': 25} |
15,242 |
1
JANSSEN, L.P.
RISPERDAL CONSTA
(risperidone)
LONG-ACTING INJECTION
Increased Mortality in Elderly Patients with Dementia –Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical
antipsychotic drugs are at an increased risk of death compared to placebo.
Analyses of seven... | custom-source | 2025-02-12T13:54:27.794629 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021346s013lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 13} |
15,243 |
1
JANSSEN, L.P.
RISPERDAL® CONSTA®
(RISPERIDONE)
LONG-ACTING INJECTION
Increased Mortality in Elderly Patients with Dementia –Related Psychosis
Elderly patients with dementia-related psychosis treated with atypical
antipsychotic drugs are at an increased risk of death compared to placebo.
Analyses of sevent... | custom-source | 2025-02-12T13:54:27.884907 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021346s020lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 20} |
15,244 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RISPERDAL® CONSTA® safely and effectively. See full prescribing
information for RISPERDAL® CONSTA®.
RISPERDAL® CONSTA® (risperidone) LONG-ACTING INJECTION
Initial U.S. Approval: 2003
WARNING: INCREASED... | custom-source | 2025-02-12T13:54:28.090211 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021346s021s022s023s026lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 22} |
15,245 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RISPERDAL® CONSTA® safely and effectively. See full prescribing
information for RISPERDAL® CONSTA®.
RISPERDAL® CONSTA® (risperidone) LONG-ACTING INJECTION
Initial U.S. Approval: 2003
WARNING: INCREASED MORT... | custom-source | 2025-02-12T13:54:28.219392 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 31} |
15,248 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RISPERDAL® CONSTA® safely and effectively. See full prescribing
information for RISPERDAL® CONSTA®.
RISPERDAL® CONSTA® (risperidone) LONG-ACTING INJECTION
Initial U.S. Approval: 2003
WARNING: INCREASED MORT... | custom-source | 2025-02-12T13:54:28.994738 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 39} |
15,247 |
HIGHLIGHTS OF... | custom-source | 2025-02-12T13:54:29.036139 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 33} |
15,246 |
... | custom-source | 2025-02-12T13:54:29.241826 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 32} |
15,249 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the inf... | custom-source | 2025-02-12T13:54:31.210378 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272s063,020588s051,021346s040,021444s039lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 40} |
15,251 |
... | custom-source | 2025-02-12T13:54:31.895691 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s042lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 42} |
15,252 |
HIGHLIGHTS OF PRESCRI... | custom-source | 2025-02-12T13:54:31.944433 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s037s043lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 43} |
15,250 |
... | custom-source | 2025-02-12T13:54:31.961324 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021346s032s041lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 41} |
15,253 |
HIGHLIGHTS ... | custom-source | 2025-02-12T13:54:32.251868 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021346s051lbl.pdf', 'application_number': 21346, 'submission_type': 'SUPPL ', 'submission_number': 51} |
15,254 | NDA 21-350
Page 3
TRIGLIDE™
(fenofibrate) tablets
DESCRIPTION
TRIGLIDE™ (fenofibrate) tablets, is a lipid-regulating agent available as tablets for oral
administration.
Each tablet contains 50 mg or 160 mg of fenofibrate.
The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-met... | custom-source | 2025-02-12T13:54:32.616608 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021350lbl.pdf', 'application_number': 21350, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,256 |
logo
DESCRIPTION
TRIGLIDE® (fenofibrate) tablets is a lipid-regulating agent available as tablets for oral
administration.
Each tablet contains 50 mg or 160 mg of fenofibrate.
The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy] 2-methyl-propanoic acid, 1
methyleth... | custom-source | 2025-02-12T13:54:32.648976 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021350s008lbl.pdf', 'application_number': 21350, 'submission_type': 'SUPPL ', 'submission_number': 8} |
15,255 |
DESCRIPTION
TRIGLIDE® (fenofibrate) tablets is a lipid-regulating agent available as tablets for oral
administration.
Each tablet contains 50 mg or 160 mg of fenofibrate.
The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy] 2-methyl-propanoic acid, 1-
methylethyl ester with the following str... | custom-source | 2025-02-12T13:54:33.021327 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021350s005lbl.pdf', 'application_number': 21350, 'submission_type': 'SUPPL ', 'submission_number': 5} |
15,257 | NDA 21-351
Page 3
OXYTROL
Oxybutynin Transdermal System
DESCRIPTION
OXYTROL, oxybutynin transdermal system, is designed to deliver oxybutynin continuously and
consistently over a 3- to 4-day interval after application to intact skin. OXYTROL is available as a 39
cm2 system containing 36 mg of oxybut... | custom-source | 2025-02-12T13:54:33.028682 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021351lbl.pdf', 'application_number': 21351, 'submission_type': 'ORIG ', 'submission_number': 1} |
15,258 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlig... | custom-source | 2025-02-12T13:54:33.689823 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021351s008s009lbl.pdf', 'application_number': 21351, 'submission_type': 'SUPPL ', 'submission_number': 9} |
15,259 |
... | custom-source | 2025-02-12T13:54:33.704187 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021351s016lbl.pdf', 'application_number': 21351, 'submission_type': 'SUPPL ', 'submission_number': 16} |
15,260 |
... | custom-source | 2025-02-12T13:54:33.925374 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s002lbl.pdf', 'application_number': 21355, 'submission_type': 'SUPPL ', 'submission_number': 2} |
15,261 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ANGELIQ... | custom-source | 2025-02-12T13:54:33.962652 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s003lbl.pdf', 'application_number': 21355, 'submission_type': 'SUPPL ', 'submission_number': 3} |
15,262 |
... | custom-source | 2025-02-12T13:54:34.646660 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021355s006lbl.pdf', 'application_number': 21355, 'submission_type': 'SUPPL ', 'submission_number': 6} |
15,264 | NDA 21-356/S-003
Page 4
VIREAD
(tenofovir disoproxil fumarate) Tablets
RxOnly
DESCRIPTION
VIREAD is the brand name for tenofovir disoproxil fumarate (a prodrug of tenofovir) which is a
fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. In vivo
tenofovir disopro... | custom-source | 2025-02-12T13:54:34.745663 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356se5-003_viread_lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 3} |
15,263 | VIREAD® (tenofovir disoproxil fumarate) 300mg TABLETS
PROPOSED FINAL PI and PPI
September 25, 2002
VIREAD
(tenofovir disoproxil fumarate) Tablets
RxOnly
DESCRIPTION
VIREAD is the brand name for tenofovir disoproxil fumarate (a prodrug of tenofovir) which is
a fumaric acid salt of bis-isoprop... | custom-source | 2025-02-12T13:54:34.834968 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21356slr001_Viread_lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 1} |
15,265 | NDA 21-346/S-005
Page 3
VIREAD
(tenofovir disoproxil fumarate) Tablets
RxOnly
DESCRIPTION
VIREAD is the brand name for tenofovir disoproxil fumarate (a prodrug of tenofovir)
which is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of
tenofovir. In vivo tenofovir disoproxi... | custom-source | 2025-02-12T13:54:34.874416 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356slr005_viread_lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 5} |
15,267 | 06-25-2004 VERSION
Viread PI redline version
Gilead Sciences
3
16 December 2003 Draft; Revisions as of 6/25/04
VIREAD
(tenofovir disoproxil fumarate) Tablets
RxOnly
DESCRIPTION
VIREAD is the brand name for tenofovir disoproxil fumarate (a prodrug of tenofovir)
which is a fumaric acid salt of bis-i... | custom-source | 2025-02-12T13:54:35.847102 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21356slr010_viread_lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 10} |
15,268 | NDA 21-356/S-011
Page 4
VIREAD®
(tenofovir disoproxil fumarate) Tablets
RxOnly
DESCRIPTION
VIREAD® is the brand name for tenofovir disoproxil fumarate (a prodrug of tenofovir) which is
a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. In vivo
te... | custom-source | 2025-02-12T13:54:35.873856 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021356s011lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 11} |
15,266 | NDA 21-346/S-006
Page 3
VIREAD
(tenofovir disoproxil fumarate) Tablets
RxOnly
DESCRIPTION
VIREAD is the brand name for tenofovir disoproxil fumarate (a prodrug of tenofovir)
which is a fumaric acid salt of bis-isopropoxycarbonyloxymethyl ester derivative of
tenofovir. In vivo tenofovir disoproxi... | custom-source | 2025-02-12T13:54:35.876748 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21356slr006_viread_lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 6} |
15,269 |
Gilead Sciences
1
VIREAD®
(tenofovir disoproxil fumarate) Tablets
℞ Only
WARNINGS
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF
NUCLEOSIDE ANALOGS ALONE OR IN COMBINATION WITH OTHER
ANTIRETROVIRALS (SEE WARNINGS).
VIREAD IS NOT APPR... | custom-source | 2025-02-12T13:54:35.960900 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021356s021,021752s011lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 21} |
15,272 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VIREAD safely and effectively. See full prescribing information
for VIREAD.
VIREAD
® (tenofovir disoproxil fumarate) tablets
Initial U.S. Approval: 2001
WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY
WITH STEA... | custom-source | 2025-02-12T13:54:37.292487 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021356s028lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 28} |
15,273 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the informa... | custom-source | 2025-02-12T13:54:37.468565 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s034lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 34} |
15,270 | •
Decreases in bone mineral density (BMD): Observed in HIV-
HIGHLIGHTS OF PRESCRIBING INFORMATION
infected patients. Consider monitoring BMD in patients with a
These highlights do not include all the information needed to use
history of pathologic fracture or who are at risk for osteopenia.
VIREAD safely and ef... | custom-source | 2025-02-12T13:54:37.525843 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021356s025lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 25} |
15,271 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Vi READ safely and effectively. See full prescribing information
forVIREAD.
VIREAD~ (tenofovir disoproxil fumarate) tablets
Initial U.S. Approval: 2001
WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY
WITH STEATO... | custom-source | 2025-02-12T13:54:37.719973 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021356s027lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 27} |
15,274 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the informati... | custom-source | 2025-02-12T13:54:38.165004 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021356s035lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 35} |
15,275 |
--------------------------WARNINGS AND PRECAUTIONS---------------------
HIGHLIGHTS OF PRESCRIBING IN... | custom-source | 2025-02-12T13:54:38.796829 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s038lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 38} |
15,276 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not ... | custom-source | 2025-02-12T13:54:38.885010 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021356s041lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 41} |
15,277 |
... | custom-source | 2025-02-12T13:54:38.914874 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021356s042,022577s002lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 42} |
15,278 |
... | custom-source | 2025-02-12T13:54:39.272782 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021356s046,022577s003lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 46} |
15,281 | MultihanceQ!
(gadobenate dimeglumine) injection, 529 mg/mL
WARNING:
NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF)
in patients with:
. acute or chronic severe renal insufficiency (glomerular
filtration rate ~30
mL/min/1.73m2), or
. a... | custom-source | 2025-02-12T13:54:39.421432 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021357s004lbl.pdf', 'application_number': 21357, 'submission_type': 'SUPPL ', 'submission_number': 4} |
15,279 |
... | custom-source | 2025-02-12T13:54:39.791376 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021356s052,022577s009lbl.pdf', 'application_number': 21356, 'submission_type': 'SUPPL ', 'submission_number': 52} |
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