Application 020509

Type: NDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GEMZAR	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MG BASE/VIAL	Yes	Yes
002	GEMZAR	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020509-001	GEMZAR	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15
N020509-002	GEMZAR	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020509-001	GEMZAR	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020509-002	GEMZAR	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1996-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020509-001	GEMZAR	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1996-05-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020509-002	GEMZAR	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1996-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020509-001	GEMZAR	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1996-05-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020509-002	GEMZAR	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1996-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020509-001	GEMZAR	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1996-05-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020509-002	GEMZAR	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1996-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020509-001	GEMZAR	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020509-002	GEMZAR	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1996-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020509-001	GEMZAR	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1996-05-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020509-002	GEMZAR	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD	1996-05-15	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020509-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020509-002	AP	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	N020509-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020509-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020509-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020509-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020509-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020509-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020509-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020509-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020509-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020509-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020509-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020509-002	AP	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemcitabine	GEMCITABINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	c0b1b715-9ff8-43ca-9e49-465f1f380084	2025-07-23	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
GEMCITABINE	GEMCITABINE HYDROCHLORIDE	NorthStar Rx LLC	5af49a48-f1c0-467d-b5da-ac9f1ae8e34c	2025-02-03	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
GEMCITABINE	GEMCITABINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	a5949d02-29eb-4626-ad35-b7614bb0fa95	2025-01-29	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
Gemcitabine hydrochloride	GEMCITABINE HYDROCHLORIDE	Teyro Labs Private Limited	a6ddaa2f-4c17-430f-a7cd-96b6662923f6	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
Gemcitabine	GEMCITABINE HYDROCHLORIDE	Mylan Institutional LLC	06dd9d40-74fc-4409-93b1-a46be7126331	2024-11-11	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride	GEMCITABINE HYDROCHLORIDE	Gland Pharma Limited	9f8fe5ba-943f-4f0a-9618-6083101faa28	2024-09-06	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
gemcitabine	GEMCITABINE HYDROCHLORIDE	Sagent Pharmaceuticals	44bcc16c-341d-49e8-a1c6-95d084667aca	2024-09-06	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE
Gemcitabine	GEMCITABINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	73ae04d8-38f9-4d3d-b0c2-71d22af1fc86	2024-08-05	Warnings, Adverse reactions	Name fallback generic name: GEMCITABINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-7501	Gemzar	Gemcitabine hydrochloride	Eli Lilly and Company	NDA	Current
0002-7501	Gemzar	Gemcitabine hydrochloride	Eli Lilly and Company	NDA	Current
0002-7501	Gemzar	Gemcitabine hydrochloride	Eli Lilly and Company	NDA	Current
0002-7502	Gemzar	Gemcitabine hydrochloride	Eli Lilly and Company	NDA	Current
0002-7502	Gemzar	Gemcitabine hydrochloride	Eli Lilly and Company	NDA	Current
0002-7502	Gemzar	Gemcitabine hydrochloride	Eli Lilly and Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58766	SUPPL	2019-05-17
58722	SUPPL	2019-05-15
57656	ORIG	2019-02-15
56696	SUPPL	2018-12-10
56555	SUPPL	2018-11-23
54666	SUPPL	2018-06-21
49803	SUPPL	2017-09-19
49735	SUPPL	2017-09-14
12661	SUPPL	2015-10-13
2632	SUPPL	2014-06-12
34741	SUPPL	2014-05-12
25080	SUPPL	2014-05-12
34740	SUPPL	2013-05-08
12660	SUPPL	2011-02-09
12659	SUPPL	2010-03-26
25079	SUPPL	2010-03-24
20689	SUPPL	2008-02-19
41404	SUPPL	2007-11-19
25078	SUPPL	2006-07-21
2631	SUPPL	2006-04-07
34739	SUPPL	2005-04-28
25077	SUPPL	2005-04-28
12658	SUPPL	2005-04-28
2630	SUPPL	2005-04-28
25076	SUPPL	2005-04-07
2629	SUPPL	2004-05-26
12657	SUPPL	2004-05-19
12656	SUPPL	2003-03-07
2628	SUPPL	2002-05-01
34738	SUPPL	1998-08-25
2627	SUPPL	1998-08-25
66910	ORIG	1900-01-01
51964	SUPPL	1900-01-01