id int64 737 80.8k | text stringlengths 1 1.03M ⌀ | source stringclasses 1
value | added stringlengths 26 26 | metadata stringlengths 156 263 |
|---|---|---|---|---|
737 |
DRAXIMAGE® M A A
Kit for the Preparation of
Technetium Tc 99m
Albumin Aggregated Injection
DIAGNOSTIC - For Intravenous Use
DESCRIPTION
The kit consists of reaction vials which contain the sterile, nonpyrogenic, non-radioactive
ingredients necessary to produce ... | custom-source | 2025-02-12T13:43:19.270381 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017881s010lbl.pdf', 'application_number': 17881, 'submission_type': 'SUPPL ', 'submission_number': 10} |
1,070 |
1
A2.0 NL 4550 AMP
1
INFORMATION FOR THE PATIENT
2
HUMULIN® R
3
REGULAR
4
INSULIN HUMAN INJECTION, USP
5
(rDNA ORIGIN)
6
100 Units per mL (U-100)
7
8
WARNINGS
9
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM
10
ANIMAL-SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL
11
TO THE INSULIN PROD... | custom-source | 2025-02-12T13:43:19.319839 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18780scm080_humalog_lbl.pdf', 'application_number': 18780, 'submission_type': 'SUPPL ', 'submission_number': 80} |
738 |
DRAXIMAGE® M A A
Kit for the Preparation of
Technetium Tc 99m
Albumin Aggregated Injection
DIAGNOSTIC - For Intravenous Use
DESCRIPTION
The kit consists of reaction vials which contain the sterile, non-pyrogenic, non
radioactive ingredients necessary to produce Technetiu... | custom-source | 2025-02-12T13:43:19.317159 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017881s016lbl.pdf', 'application_number': 17881, 'submission_type': 'SUPPL ', 'submission_number': 16} |
1,071 | 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
| custom-source | 2025-02-12T13:43:19.393704 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf', 'application_number': 18780, 'submission_type': 'SUPPL ', 'submission_number': 86} |
1,078 |
... | custom-source | 2025-02-12T13:43:19.755469 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018780s153lbl.pdf', 'application_number': 18780, 'submission_type': 'SUPPL ', 'submission_number': 153} |
1,074 |
A3.03 NL 5990 AMP
INFORMATION FOR THE PHYSICIAN
HUMULIN® R
REGULAR
INSULIN HUMAN INJECTION, USP,
(rDNA ORIGIN)
100 UNITS PER ML (U-100)
DESCRIPTION
Humulin® R U-100 is a polypeptide hormone structurally identical to human insulin
synthesized through rDNA technology in a special non-disease-pro... | custom-source | 2025-02-12T13:43:19.837218 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018780s120lbl.pdf', 'application_number': 18780, 'submission_type': 'SUPPL ', 'submission_number': 120} |
1,082 |
1
A3.0 NL 3680 AMP
1
INFORMATION FOR THE PATIENT
2
3 ML DISPOSABLE INSULIN DELIVERY DEVICE
3
HUMULIN® N Pen
4
NPH
5
HUMAN INSULIN
6
(rDNA ORIGIN) ISOPHANE SUSPENSION
7
100 UNITS PER ML (U-100)
8
WARNINGS
9
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL-
10
SOURCE INSULINS BECAUSE IT IS STR... | custom-source | 2025-02-12T13:43:19.969401 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18781scm074_humulin_lbl.pdf', 'application_number': 18781, 'submission_type': 'SUPPL ', 'submission_number': 74} |
1,077 |
... | custom-source | 2025-02-12T13:43:20.081784 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018780s135s152lbl.pdf', 'application_number': 18780, 'submission_type': 'SUPPL ', 'submission_number': 135} |
1,083 |
5.01 PA 9135 FSAMP
1
INFORMATION FOR THE PATIENT
2
3 ML DISPOSABLE INSULIN DELIVERY DEVICE
3
HUMULIN® N Pen
4
NPH
5
HUMAN INSULIN
6
(rDNA ORIGIN) ISOPHANE SUSPENSION
7
100 UNITS PER ML (U-100)
8
WARNINGS
9
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL-
10
SOURCE INSULINS BECAUSE IT IS STRU... | custom-source | 2025-02-12T13:43:20.185797 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18781slr076_humulin_lbl.pdf', 'application_number': 18781, 'submission_type': 'SUPPL ', 'submission_number': 76} |
1,085 | 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
| custom-source | 2025-02-12T13:43:20.188077 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18780s086,18781s080lbl.pdf', 'application_number': 18781, 'submission_type': 'SUPPL ', 'submission_number': 80} |
1,087 |
1
1
2
INFORMATION FOR THE PATIENT
3
10 mL Vial (1000 Units per vial)
4
HUMULIN® N
5
NPH
6
HUMAN INSULIN (rDNA ORIGIN)
7
ISOPHANE SUSPENSION
8
100 UNITS PER ML (U-100)
9
WARNINGS
10
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL
11
SOURCE INSULINS BECAUSE IT IS STRUCTURALLY ... | custom-source | 2025-02-12T13:43:20.417590 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018781s114lbl.pdf', 'application_number': 18781, 'submission_type': 'SUPPL ', 'submission_number': 114} |
1,086 | Instructions for Use
Read and follow all of these instructions
carefully. If you do not follow these
instructions completely, you may get
too much or too little insulin.
Every time you inject:
• Use a new needle
• Prime to make sure the Pen is
ready to dose
• Make sure you got a full dose
(see page 18)
Also, read th... | custom-source | 2025-02-12T13:43:20.479873 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018781s025,060,065,085lbl.pdf', 'application_number': 18781, 'submission_type': 'SUPPL ', 'submission_number': 85} |
1,088 | 1
A3.0NL 5712 AMP
INFORMATION FOR THE PATIENT
10 mL Vial (1000 Units per vial)
HUMULIN® N
NPH
HUMAN INSULIN (rDNA ORIGIN)
ISOPHANE SUSPENSION
100 UNITS PER ML (U-100)
WARNINGS
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL-
SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL TO THE
INSULIN PRODUCED BY... | custom-source | 2025-02-12T13:43:20.584929 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s121lbl.pdf', 'application_number': 18781, 'submission_type': 'SUPPL ', 'submission_number': 121} |
1,089 |
... | custom-source | 2025-02-12T13:43:20.728227 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018781s118s122lbl.pdf', 'application_number': 18781, 'submission_type': 'SUPPL ', 'submission_number': 122} |
1,527 | 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
----------------------------------------------------------... | custom-source | 2025-02-12T13:43:20.897244 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19717s41lbl.pdf', 'application_number': 19717, 'submission_type': 'SUPPL ', 'submission_number': 41} |
1,090 | 1
... | custom-source | 2025-02-12T13:43:21.080403 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018781s154lbl.pdf', 'application_number': 18781, 'submission_type': 'SUPPL ', 'submission_number': 154} |
1,528 |
1
5.0 PA 9143-A FSAMP
1
INFORMATION FOR THE PATIENT
2
3 ML DISPOSABLE INSULIN DELIVERY DEVICE
3
HUMULIN® 70/30 Pen
4
70% HUMAN INSULIN
5
ISOPHANE SUSPENSION
6
AND
7
30% HUMAN INSULIN INJECTION
8
(rDNA ORIGIN)
9
100 Units per mL (U-100)
10
WARNINGS
11
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FRO... | custom-source | 2025-02-12T13:43:21.178364 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717slr050_humilin_lbl.pdf', 'application_number': 19717, 'submission_type': 'SUPPL ', 'submission_number': 50} |
1,529 |
1
A3.0 NL 3670 AMP
1
INFORMATION FOR THE PATIENT
2
3 ML DISPOSABLE INSULIN DELIVERY DEVICE
3
HUMULIN 70/30 Pen
4
70% HUMAN INSULIN
5
ISOPHANE SUSPENSION
6
AND
7
30% HUMAN INSULIN INJECTION
8
(rDNA ORIGIN)
9
100 UNITS PER ML (U-100)
10
WARNINGS
11
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM A... | custom-source | 2025-02-12T13:43:21.272133 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19717scm054_humulin_lbl.pdf', 'application_number': 19717, 'submission_type': 'SUPPL ', 'submission_number': 54} |
1,532 |
1
A1.0 NL 5691 AMP
A1.0 NL 5681 AMP
A2.0 NL 4460 AMP
INFORMATION FOR THE PATIENT
10 mL Vial (1000 Units per vial)
HUMULIN® R
REGULAR
INSULIN HUMAN INJECTION, USP
(rDNA ORIGIN)
100 UNITS PER ML (U-100)
WARNINGS
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM
ANIMAL-SOURCE INSULINS BECAUSE IT IS STRUCTURAL... | custom-source | 2025-02-12T13:43:21.517342 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018780s95,018781s89,019717s69,020100s32lbl.pdf', 'application_number': 19717, 'submission_type': 'SUPPL ', 'submission_number': 69} |
1,534 |
1
1
2
INFORMATION FOR THE PATIENT
3
10 mL Vial (1000 Units per vial)
4
HUMULIN® 70/30
5
70% HUMAN INSULIN
6
ISOPHANE SUSPENSION
7
AND
8
30% HUMAN INSULIN INJECTION
9
(rDNA ORIGIN)
10
100 UNITS PER ML (U-100)
11
WARNINGS
12
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL
13 ... | custom-source | 2025-02-12T13:43:21.547561 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019717s094lbl.pdf', 'application_number': 19717, 'submission_type': 'SUPPL ', 'submission_number': 94} |
1,530 | 2.0 PV 3672 AMP
1
INFORMATION FOR THE PATIENT
2
3 ML DISPOSABLE INSULIN DELIVERY DEVICE
3
HUMULIN® 70/30 Pen
4
70% HUMAN INSULIN
5
ISOPHANE SUSPENSION
6
AND
7
30% HUMAN INSULIN INJECTION
8
(rDNA ORIGIN)
9
100 UNITS PER ML (U-100)
10
WARNINGS
11
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL-... | custom-source | 2025-02-12T13:43:21.626530 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19717s060lbl.pdf', 'application_number': 19717, 'submission_type': 'SUPPL ', 'submission_number': 60} |
1,535 |
... | custom-source | 2025-02-12T13:43:21.837852 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s098s101lbl.pdf', 'application_number': 19717, 'submission_type': 'SUPPL ', 'submission_number': 98} |
1,536 | 1
A3.0NL 5723 AMP
INFORMATION FOR THE PATIENT
10 mL Vial (1000 Units per vial)
3 mL Vial (300 Units per vial)
HUMULIN® 70/30
70% HUMAN INSULIN
ISOPHANE SUSPENSION
AND
30% HUMAN INSULIN INJECTION
(rDNA ORIGIN)
100 UNITS PER ML (U-100)
WARNINGS
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL-SOURCE
INS... | custom-source | 2025-02-12T13:43:21.919182 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s099lbl.pdf', 'application_number': 19717, 'submission_type': 'SUPPL ', 'submission_number': 99} |
1,537 |
... | custom-source | 2025-02-12T13:43:22.068876 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019717s098s101lbl.pdf', 'application_number': 19717, 'submission_type': 'SUPPL ', 'submission_number': 101} |
1,539 | 1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
HUMULIN 70/30 safely and effectively. See full prescribing
information for HUMULIN 70/30.
HUMULIN® 70/30 (70% human insulin isophane suspension and
30% human insulin injection [rDNA origin]) injectable suspen... | custom-source | 2025-02-12T13:43:22.266329 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019717s133lbl.pdf', 'application_number': 19717, 'submission_type': 'SUPPL ', 'submission_number': 133} |
1,819 | NDA 19-938/S-037
Page 1
NNPI submission date: 5/17/05
NovoPen®3
PenMate®
Instruction Manual
For use with the
following NovoPen® insulin delivery
devices:
NovoPen®3,
NovoPen® 3 Demi,
or NovoPen® Junior
Read this carefully before you use
NovoPen®3 PenMate® with
NovoPen®3, NovoPen® 3 Demi, o... | custom-source | 2025-02-12T13:43:22.487492 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019938s037lbl.pdf', 'application_number': 19938, 'submission_type': 'SUPPL ', 'submission_number': 37} |
1,818 | 1
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NovoPen 3 PenMate Instruction Manual
Page 2
FDA revision #4 (final)
2
NovoPen® 3
3
previous page for graphic
4
PenMate®
5
6
Instruction Manual
7
8
Read this carefully
9
before you use
10
... | custom-source | 2025-02-12T13:43:22.507522 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf', 'application_number': 19938, 'submission_type': 'SUPPL ', 'submission_number': 30} |
1,821 |
Novopen Illustration
Introduction
Read the Patient Instructions for Use that comes with NovoPen
4 before you start using it and each time you get a refill. There
may be new information. This leaflet does not take the place of
talking wit... | custom-source | 2025-02-12T13:43:22.589838 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf', 'application_number': 19938, 'submission_type': 'SUPPL ', 'submission_number': 64} |
1,820 |
R HUMAN
Novo Nordisk®
Patient Information for Novolin® R
NOVOLIN® R (NO-voe-lin)
Regular,
Human Insulin Injection
(recombinant DNA origin) USP
100 units/mL
Important:
Know your insulin. Do not change the type of insulin you use unless told to do so by
your healt... | custom-source | 2025-02-12T13:43:22.684106 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf', 'application_number': 19938, 'submission_type': 'SUPPL ', 'submission_number': 63} |
1,857 |
R HUMAN
Novo Nordisk®
Patient Information for Novolin® R
NOVOLIN® R (NO-voe-lin)
Regular,
Human Insulin Injection
(recombinant DNA origin) USP
100 units/mL
Important:
Know your insulin. Do not change the type of insulin you use unless told to do so by
your healt... | custom-source | 2025-02-12T13:43:22.817590 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s063,019959s066,019991s067lbl.pdf', 'application_number': 19959, 'submission_type': 'SUPPL ', 'submission_number': 66} |
1,862 | N HUMAN
Novo Nordisk®
Patient Information for Novolin® N
NOVOLIN® N (NO-voe-lin)
NPH,
Human Insulin Isophane Suspension Injection
(recombinant DNA origin)
100 units/mL
Important:
Know your insulin. Do not change the type of insulin you use unless told to do so by
your healthcare provider. The amount o... | custom-source | 2025-02-12T13:43:23.092367 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019959s073lbl.pdf', 'application_number': 19959, 'submission_type': 'SUPPL ', 'submission_number': 73} |
1,856 | 1
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NovoPen 3 PenMate Instruction Manual
Page 2
FDA revision #4 (final)
2
NovoPen® 3
3
previous page for graphic
4
PenMate®
5
6
Instruction Manual
7
8
Read this carefully
9
before you use
10
... | custom-source | 2025-02-12T13:43:23.105660 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf', 'application_number': 19959, 'submission_type': 'SUPPL ', 'submission_number': 31} |
1,858 |
Novopen Illustration
Introduction
Read the Patient Instructions for Use that comes with NovoPen
4 before you start using it and each time you get a refill. There
may be new information. This leaflet does not take the place of
talking wit... | custom-source | 2025-02-12T13:43:23.107895 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf', 'application_number': 19959, 'submission_type': 'SUPPL ', 'submission_number': 67} |
1,863 |
N HUMAN
Novo Nordisk®
Patient Information for Novolin® N
NOVOLIN® N (NO-voe-lin)
NPH,
Human Insulin ... | custom-source | 2025-02-12T13:43:23.195474 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019959s075lbl.pdf', 'application_number': 19959, 'submission_type': 'SUPPL ', 'submission_number': 75} |
1,886 | 1
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NovoPen 3 PenMate Instruction Manual
Page 2
FDA revision #4 (final)
2
NovoPen® 3
3
previous page for graphic
4
PenMate®
5
6
Instruction Manual
7
8
Read this carefully
9
before you use
10
... | custom-source | 2025-02-12T13:43:23.431239 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19-938S30lbl.pdf', 'application_number': 19991, 'submission_type': 'SUPPL ', 'submission_number': 32} |
1,888 | 1
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDAs 19-938, 19-959, 19-991, & 20-986
NovoPen 3 Demi Final revision
Page 2
2
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www... | custom-source | 2025-02-12T13:43:23.565374 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s33lbl.pdf', 'application_number': 19991, 'submission_type': 'SUPPL ', 'submission_number': 36} |
1,891 | 70/30 HUMAN
Novo Nordisk®
Patient Information for Novolin® 70/30
NOVOLIN® 70/30 (NO-voe-lin)
70% NPH, Human Insulin Isophane Suspension and
30% Regular, Human Insulin Injection
(recombinant DNA origin)
100 units/mL
Important:
Know your insulin. Do not change the type of insulin you use unless told to do... | custom-source | 2025-02-12T13:43:23.624053 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019991s074lbl.pdf', 'application_number': 19991, 'submission_type': 'SUPPL ', 'submission_number': 74} |
1,887 | NDAs 19-938, 19-959, 19-991, & 20-986
NovoPen Junior Final revision
Page 1
1
This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
NDAs 19-938, 19-959, 19-991, & 20-986
NovoPen Junior Final revision
Page 2
2
This label may not be the latest ap... | custom-source | 2025-02-12T13:43:23.692609 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19938s32lbl.pdf', 'application_number': 19991, 'submission_type': 'SUPPL ', 'submission_number': 35} |
2,288 | NDA 20-280/S-040
GENOTROPIN ZipTip
Needle-free Delivery Device for use with Genotropin® Lyophilized Powder (somatropin [rDNA
origin] for injection)
Instructions for Use
Important Note
Please read these instructions completely before using the
GENOTROPIN ZipTip. If there is anything you
do n... | custom-source | 2025-02-12T13:43:23.826271 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20280scs040_genotropin_lbl.pdf', 'application_number': 20280, 'submission_type': 'SUPPL ', 'submission_number': 40} |
2,290 |
Division Director Memo
NDA #
20-280/Supplement 060
Applicant
Pfizer
Drug Product
Genotropin® (recombinant human growth
hormone)
Indication
Idiopathic Short Stature
Background
Pfizer has submitted this efficacy supplement to expand the ind... | custom-source | 2025-02-12T13:43:23.931800 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020280se1-060_SUMR.pdf', 'application_number': 20280, 'submission_type': 'SUPPL ', 'submission_number': 60} |
2,291 |
_________________________________________________________________________________________________________________________... | custom-source | 2025-02-12T13:43:24.230305 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020280s064lbl.pdf', 'application_number': 20280, 'submission_type': 'SUPPL ', 'submission_number': 64} |
3,207 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CREON... | custom-source | 2025-02-12T13:43:24.232380 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s003lbl.pdf', 'application_number': 20725, 'submission_type': 'SUPPL ', 'submission_number': 3} |
3,208 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CREON
safely and ef... | custom-source | 2025-02-12T13:43:24.393379 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s006lbl.pdf', 'application_number': 20725, 'submission_type': 'SUPPL ', 'submission_number': 6} |
2,292 |
____________________________________________________________________________________________... | custom-source | 2025-02-12T13:43:24.517036 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020280s071lbl.pdf', 'application_number': 20280, 'submission_type': 'SUPPL ', 'submission_number': 71} |
3,209 |
1
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CREON
safely and ... | custom-source | 2025-02-12T13:43:24.643779 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s007lbl.pdf', 'application_number': 20725, 'submission_type': 'SUPPL ', 'submission_number': 7} |
3,211 |
NDA 020725/S-011
Page 4
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CREON
safely and effectively. Se... | custom-source | 2025-02-12T13:43:24.781761 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020725s011lbl.pdf', 'application_number': 20725, 'submission_type': 'SUPPL ', 'submission_number': 11} |
3,938 | custom-source | 2025-02-12T13:43:24.803320 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-986SE3003_NovoLog_prntlbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 3} | |
3,939 | NDA 20-986/S-011
Final Draft
Page 1
NNPI submission date: 11/26/02
NovoLog®
1
Insulin aspart (rDNA origin) Injection
2
3
4
DESCRIPTION
5
NovoLog® (insulin aspart [rDNA origin] injection) is a human insulin analog that is a rapid-
6
acting, parenteral blood glucose-lowering agent. NovoLog is homologous with regular hu... | custom-source | 2025-02-12T13:43:24.953344 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20986SE8-011_novolog_lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 11} |
3,942 | NDA 20-986/S-024
Final DRAFT
Page 1
Novo Nordisk submission date: 7/26/04
NovoLog®
1
Insulin aspart (rDNA origin) Injection
2
3
4
DESCRIPTION
5
NovoLog® (insulin aspart [rDNA origin] injection) is a human insulin analog that is a rapid-
6
acting, parenteral blood glucose-lowering agent. NovoLo... | custom-source | 2025-02-12T13:43:25.581464 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s024lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 24} |
3,941 | NDA 20-986/S-023
Page 1
NNPI Submission date 4/6/04
NovoLog®
1
Insulin aspart (rDNA origin) Injection
2
3
4
DESCRIPTION
5
NovoLog® (insulin aspart [rDNA origin] injection) is a human insulin analog that is a rapid-
6
acting, parenteral blood glucose-lowering agent. NovoLog is homologo... | custom-source | 2025-02-12T13:43:25.950153 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986scp023_novolog_lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 23} |
3,940 | 2
8
8-xxxx-31-
xxx-x
Code centre line
Code: 100% Direction
Length: Max 29 mm (100%)
22-503-30
Exp. Date/Control:
RA Labelling & Graphics
Carton: 22-503-30-30X
Current 1.0
Lacquer free area:
Lacquerform: 30048-2
Colour: PMS 280C
+ Black + PMS 151C
+ PMS 289C
100 units/mL (U-100)
5×3 mL Prefilled Insulin Syringes
Rx o... | custom-source | 2025-02-12T13:43:26.020781 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20986s019,21172s013lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 19} |
3,943 | Page 1 of 16; NDA 20-986/S-037
Proposed Physician Insert
Version 10.4; Submitted 12-JAN-2007
NovoLog® Physician Insert
NovoLog®
Insulin aspart (rDNA origin) Injection
DESCRIPTION
NovoLog® (insulin aspart [rDNA origin] injection) is a human insulin analog that is a rapid-
acting, parenteral blood... | custom-source | 2025-02-12T13:43:26.172765 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020986s037lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 37} |
3,948 |
Novopen Illustration
Introduction
Read the Patient Instructions for Use that comes with NovoPen
4 before you start using it and each time you get a refill. There
may be new information. This leaflet does not take the place of
talking wit... | custom-source | 2025-02-12T13:43:26.428505 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019938s064,019959s067,019991s068,020986s055lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 55} |
3,944 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all... | custom-source | 2025-02-12T13:43:26.911536 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020986s045lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 45} |
3,945 | Page 1 of 23 Submitted 14Mar08
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NovoLog®
safely and effectively. See full prescribing information for NovoLog.
NovoLog (insulin aspart [rDNA origin] injection) solution for subcutaneous
use
Initial U.S... | custom-source | 2025-02-12T13:43:26.997037 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020986s047lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 47} |
3,949 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all... | custom-source | 2025-02-12T13:43:27.326497 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s057lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 57} |
3,951 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all... | custom-source | 2025-02-12T13:43:27.426236 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020986s064lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 64} |
3,952 |
... | custom-source | 2025-02-12T13:43:27.673213 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s078lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 78} |
3,953 |
... | custom-source | 2025-02-12T13:43:28.872945 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s080lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 80} |
4,071 |
1
1
2
HUMALOG® Mix50/50TM
3
50% INSULIN LISPRO PROTAMINE SUSPENSION AND
4
50% INSULIN LISPRO INJECTION
5
(rDNA ORIGIN)
6
100 UNITS PER ML (U-100)
7
DESCRIPTION
8
Humalog® Mix50/50™ [50% insulin lispro protamine suspension and 50% insulin lispro
9
injection, (rDNA origin)] is a mixture o... | custom-source | 2025-02-12T13:43:29.014532 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021018s077lbl.pdf', 'application_number': 21018, 'submission_type': 'SUPPL ', 'submission_number': 77} |
3,955 |
... | custom-source | 2025-02-12T13:43:29.022616 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s082lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 82} |
3,954 |
... | custom-source | 2025-02-12T13:43:29.315742 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020986s059s081lbl.pdf', 'application_number': 20986, 'submission_type': 'SUPPL ', 'submission_number': 81} |
4,072 |
HUMALOG® Mix50/50TM
50% INSULIN LISPRO PROTAMINE SUSPENSION AND
50% INSULIN LISPRO INJECTION
(rDNA ORIGIN)
100 UNITS PER ML (U-100)
DESCRIPTION
Humalog® Mix50/50™ [... | custom-source | 2025-02-12T13:43:29.636565 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021018s100lbl.pdf', 'application_number': 21018, 'submission_type': 'SUPPL ', 'submission_number': 100} |
4,543 | NDA 21-172/S-003
FDA revision date (6/16/02)
Novo’s submission date: 6/13/02
Page 1
NovoLog Mix 70/30
(70% insulin aspart [rDNA origin] protamine suspension and 30%
insulin aspart [rDNA origin] injection)
1
DESCRIPTION
2
NovoLog Mix 70/30 (70% insulin aspart [rDNA origin] protamine suspension and 30% insulin aspart
3
[... | custom-source | 2025-02-12T13:43:29.798109 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21172s3lbl.pdf', 'application_number': 21172, 'submission_type': 'SUPPL ', 'submission_number': 3} |
4,544 | NDA 21-172/S-021
Final
Page 1
Submission date: November 21, 2005
NovoLog® Mix 70/30
70% insulin aspart protamine suspension and 30% insulinaspart injection, (rDNA origin)
DESCRIPTION
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart
injection, [rDNA origin]) is a human ... | custom-source | 2025-02-12T13:43:29.811781 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021172s021lbl.pdf', 'application_number': 21172, 'submission_type': 'SUPPL ', 'submission_number': 21} |
4,545 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:43:30.174612 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021172s045s049lbl.pdf', 'application_number': 21172, 'submission_type': 'SUPPL ', 'submission_number': 49} |
4,546 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:43:30.864477 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021172s051lbl.pdf', 'application_number': 21172, 'submission_type': 'SUPPL ', 'submission_number': 51} |
5,671 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LEVEMIR® safely and effectively. See full prescribing information
for LEVEMIR.
LEVEMIR® (insulin detemir [rDNA origin] injection) solution for
subcutaneous injection
Initial U.S. Approval: 2005
------... | custom-source | 2025-02-12T13:43:30.871893 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s028lbl.pdf', 'application_number': 21536, 'submission_type': 'SUPPL ', 'submission_number': 28} |
4,547 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NovoLog Mix 70/30 safely and effectively. See full prescribing
information for NovoLog Mix 70/30.
NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30%
insulin aspart injection, [rDNA origin]... | custom-source | 2025-02-12T13:43:30.886349 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021172s053lbl.pdf', 'application_number': 21172, 'submission_type': 'SUPPL ', 'submission_number': 53} |
5,672 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
LEVEMIR® safely and effectively. See full prescribing information
for LEVEMIR.
LEVEMIR® (insulin detemir [rDNA origin] injection) solution for
subcutaneous injection
Initial U.S. Approval: 2005
--------... | custom-source | 2025-02-12T13:43:31.025515 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s035lbl.pdf', 'application_number': 21536, 'submission_type': 'SUPPL ', 'submission_number': 35} |
5,674 |
__________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:43:31.397568 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536S039lbl.pdf', 'application_number': 21536, 'submission_type': 'SUPPL ', 'submission_number': 39} |
5,675 |
__________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:43:31.488388 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s041lbl.pdf', 'application_number': 21536, 'submission_type': 'SUPPL ', 'submission_number': 41} |
5,676 |
__________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:43:31.649743 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021536s044lbl.pdf', 'application_number': 21536, 'submission_type': 'SUPPL ', 'submission_number': 44} |
5,673 |
__________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:43:31.778349 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s037lbl.pdf', 'application_number': 21536, 'submission_type': 'SUPPL ', 'submission_number': 37} |
5,879 |
_______________________________________________________________________________________________________________________________________
... | custom-source | 2025-02-12T13:43:32.030017 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021629s015lbl.pdf', 'application_number': 21629, 'submission_type': 'SUPPL ', 'submission_number': 15} |
5,945 |
... | custom-source | 2025-02-12T13:43:32.300697 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021663s014lbl.pdf', 'application_number': 21663, 'submission_type': 'SUPPL ', 'submission_number': 14} |
5,880 |
... | custom-source | 2025-02-12T13:43:32.320525 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021629s029lbl.pdf', 'application_number': 21629, 'submission_type': 'SUPPL ', 'submission_number': 29} |
6,232 | NovoLog® Mix 50/50
50% insulin aspart protamine suspension and 50% insulin aspart injection, (rDNA origin)
DESCRIPTION
NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injec-
tion, [rDNA origin]) is an insulin analog suspension containing 50% insulin aspart protamine
crystals an... | custom-source | 2025-02-12T13:43:32.433794 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021810s004lbl.pdf', 'application_number': 21810, 'submission_type': 'SUPPL ', 'submission_number': 4} |
6,233 |
NovoLog® Mix 50/50
50% insulin aspart protamine suspension and 50% insulin aspart injection, (rDNA origin)
DESCRIPTION
NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50%... | custom-source | 2025-02-12T13:43:32.704696 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021810s010lbl.pdf', 'application_number': 21810, 'submission_type': 'SUPPL ', 'submission_number': 10} |
6,279 | HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
INCRELEX® safely and effectively. See full prescribing information for
INCRELEX®.
INCRELEX® (mecasermin [rDNA origin] injection), for subcutaneous use
Initial U.S. Approval: 2005
------------------------... | custom-source | 2025-02-12T13:43:32.953629 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021839s017lbl.pdf', 'application_number': 21839, 'submission_type': 'SUPPL ', 'submission_number': 17} |
7,439 | This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
---------------------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed
electronically and... | custom-source | 2025-02-12T13:43:33.014753 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472Orig1s005lbl.pdf', 'application_number': 22472, 'submission_type': 'SUPPL ', 'submission_number': 5} |
7,440 |
... | custom-source | 2025-02-12T13:43:33.257903 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf', 'application_number': 22472, 'submission_type': 'SUPPL ', 'submission_number': 6} |
10,665 | NDA 04-782/S-115, S-130
Page 3
Premarin®
(conjugated estrogens tablets, USP)
only
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures,
including endometrial sampling when indicated, should be undertaken to rule out malign... | custom-source | 2025-02-12T13:43:33.482283 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/004782s115lbl.pdf', 'application_number': 4782, 'submission_type': 'SUPPL ', 'submission_number': 115} |
7,438 |
... | custom-source | 2025-02-12T13:43:33.588795 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s002lbl.pdf', 'application_number': 22472, 'submission_type': 'SUPPL ', 'submission_number': 2} |
7,497 |
... | custom-source | 2025-02-12T13:43:33.642436 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022523s004lbl.pdf', 'application_number': 22523, 'submission_type': 'SUPPL ', 'submission_number': 4} |
10,666 | NDA 04-782/S-128
Page 3
Premarin®
(conjugated estrogens tablets, USP)
only
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures,
including endometrial sampling when indicated, should be undertaken to rule out ma... | custom-source | 2025-02-12T13:43:33.750476 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/04782slr128_Premarin_lbl.pdf', 'application_number': 4782, 'submission_type': 'SUPPL ', 'submission_number': 128} |
10,667 | 1
Premarin®
(conjugated estrogens tablets, USP)
only
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic
measures, including endometrial sampling when indicated, should be undertaken to rule out
malignancy in all cases of undiagno... | custom-source | 2025-02-12T13:43:33.919719 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/04782s129lbl.pdf', 'application_number': 4782, 'submission_type': 'SUPPL ', 'submission_number': 129} |
10,670 |
Premarin
(conjugated estrogens tablets, USP)
Rx only
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic
measures, including endometrial sampling when indicated, should be undertaken to rule out
malignancy in all cases ... | custom-source | 2025-02-12T13:43:34.044065 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782s137lbl.pdf', 'application_number': 4782, 'submission_type': 'SUPPL ', 'submission_number': 137} |
10,668 | NDA 04-782/S-136
Page 3
Premarin
(conjugated estrogens tablets, USP)
Rx only
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures,
including endometrial sampling when indicated, should be undertaken to rule o... | custom-source | 2025-02-12T13:43:34.147933 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/04782slr133,136_premarin_lbl.pdf', 'application_number': 4782, 'submission_type': 'SUPPL ', 'submission_number': 133} |
10,671 | NDA 04-782/S-138, S-139
Page 3
Premarin
(conjugated estrogens tablets, USP)
] only
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures,
including endometrial sampling when indicated, should be undertaken to ... | custom-source | 2025-02-12T13:43:34.204206 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s138,139lbl.pdf', 'application_number': 4782, 'submission_type': 'SUPPL ', 'submission_number': 139} |
10,672 | NDA 04-782/S-142
Page 3
Premarin®
(conjugated estrogens tablets, USP)
] only
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures,
including endometrial sampling when indicated, should be undertaken to rule out ... | custom-source | 2025-02-12T13:43:34.369051 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/004782s142lbl.pdf', 'application_number': 4782, 'submission_type': 'SUPPL ', 'submission_number': 142} |
10,673 |
PREMARIN®
(conjugated estrogens tablets, USP)
Rx only
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST
CANCER and PROBABLE DEMENTIA
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed
estrogens. Adding a progestin ... | custom-source | 2025-02-12T13:43:34.525735 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/004782s162s164s167lbl.pdf', 'application_number': 4782, 'submission_type': 'SUPPL ', 'submission_number': 164} |
10,675 |
CII
Demerol® (meperidine hydrochloride, USP)
WARNING: May be habit forming
DESCRIPTION
Meperidine hydrochloride, is a white crystalline substance with a melting point of 186° C to
189° C. It is readily soluble in water and has a neutral reaction and a slightly bitter taste. The
solution is not decomposed by... | custom-source | 2025-02-12T13:43:34.585894 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s050lbl.pdf', 'application_number': 5010, 'submission_type': 'SUPPL ', 'submission_number': 50} |
10,674 |
CII
Demerol® (meperidine hydrochloride, USP)
WARNING: May be habit forming
DESCRIPTION
Meperidine hydrochloride, a white crystalline substance with a melting point of 186° C to 189°
C. It is readily soluble in water and has a neutral reaction and a slightly bitter taste. The solution
is not decomposed by a sh... | custom-source | 2025-02-12T13:43:34.608418 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005010s049lbl.pdf', 'application_number': 5010, 'submission_type': 'SUPPL ', 'submission_number': 49} |
10,676 |
CII
Demerol® (meperidine hydrochloride, USP)
WARNING: May be habit forming
DESCRIPTION
Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C. It is readily soluble in water and
has a neutral reaction and a slightly bitter taste. The solution is not decomposed by... | custom-source | 2025-02-12T13:43:34.848522 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/005010s051lbl.pdf', 'application_number': 5010, 'submission_type': 'SUPPL ', 'submission_number': 51} |
10,678 | NDA 05-929/S-032, S-033
NDA 09-000/S-022, S-023
NDA 20-148/S-007, S-008
Package Insert
Page 1
DHE 45 (NDA 05-929) and Migranal Nasal Spray (NDA 20-148)
CLINICAL PHARMACOLOGY
Pharmacokinetics: Interactions
Pharmacokinetic interactions have been reported in patients treated orally with other ergot alkaloids
(e.g., incre... | custom-source | 2025-02-12T13:43:34.894876 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/05929s32s33lbl.pdf', 'application_number': 5929, 'submission_type': 'SUPPL ', 'submission_number': 33} |
10,677 |
PHARMACIST: Med Guide PROVIDED SEPARATELY AND
IS TO BE INCLUDED WITH PRESCRIPTION FOR EACH
PATIENT. Also available at www.ovationpbarma.com.
DESOXYN®
Methamphetamine
Hydrochloride
Tablets, USP
only ... | custom-source | 2025-02-12T13:43:34.926145 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005378s026lbl.pdf', 'application_number': 5378, 'submission_type': 'SUPPL ', 'submission_number': 26} |
10,679 | NDA 5-939/S-007
Page 3
BAL in Oil Ampules
DIMERCAPROL INJECTION, USP
BAL (2, 3-dimercapto-1-propanol) 10%, Benzyl Benzoate 20%, in Peanut Oil
C3H8OS2 Molecular Weight 124.22
DESCRIPTION
Dimercaprol Injection USP is a colorless or almost colorless liquid chelating agent having a
disagreeable, me... | custom-source | 2025-02-12T13:43:34.939356 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005939s007lbl.pdf', 'application_number': 5939, 'submission_type': 'SUPPL ', 'submission_number': 7} |
10,680 |
Novartis
Methergine®
(methylergonovine maleate)
Tablets, USP
(methylergonovine maleate)
Injection, USP
Rx only
DESCRIPTION
Methergine® (methylergonovine maleate) is a semi-synthetic ergot alkaloid used for the prevention and
control of postpartum hemorrhage.
Methergine is available in ... | custom-source | 2025-02-12T13:43:35.135971 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006035s078lbl.pdf', 'application_number': 6035, 'submission_type': 'SUPPL ', 'submission_number': 78} |
10,681 |
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights... | custom-source | 2025-02-12T13:43:35.322421 | {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/006134s031lbl.pdf', 'application_number': 6134, 'submission_type': 'SUPPL ', 'submission_number': 31} |
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