Application 200795

Type: NDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	200MG/5.26ML (38MG/ML)	Yes	Yes
002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	1GM/26.3ML (38MG/ML)	Yes	Yes
003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	2GM/52.6ML (38MG/ML)	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N200795-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04
N200795-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04
N200795-003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N200795-001	AP
N200795-002	AP
N200795-003	AP

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 4 · 126 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	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200795-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200795-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200795-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2011-08-04	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N200795-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200795-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200795-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200795-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200795-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200795-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200795-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200795-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200795-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200795-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200795-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200795-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200795-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200795-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200795-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200795-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200795-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200795-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200795-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200795-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200795-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200795-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200795-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200795-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200795-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200795-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200795-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200795-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200795-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200795-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200795-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200795-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200795-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200795-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200795-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200795-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200795-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200795-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200795-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200795-001	AP	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemcitabine	GEMCITABINE	Hospira, Inc.	dc02a23b-3ff9-4441-aa91-8e9e629a7315	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200795 application number: NDA200795 ndc (product): 0409-0182 ndc (product): 0409-0183 ndc (product): 0409-0181
Gemcitabine	GEMCITABINE	Hospira, Inc.	e18ed1cb-7dd0-4001-bfda-17d1f4587fb8	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200795 application number: NDA200795 ndc (product): 0409-0182 ndc (product): 0409-0183 ndc (product): 0409-0181

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-0181	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0181	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0181	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0181	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0181	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0181	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0181	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0181	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0182	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0182	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0182	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0182	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0182	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0182	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0182	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0182	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0183	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0183	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0183	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0183	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0183	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0183	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0183	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current
0409-0183	Gemcitabine	GEMCITABINE	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78619	SUPPL	2024-06-04
78612	SUPPL	2024-06-03
59178	SUPPL	2019-06-27
59161	SUPPL	2019-06-24
52621	SUPPL	2018-02-14
52134	SUPPL	2018-01-30
32062	SUPPL	2014-05-12
18980	SUPPL	2014-05-12
32061	SUPPL	2013-09-10
40046	SUPPL	2013-09-09
43356	ORIG	2012-07-06
24388	ORIG	2012-07-06
32060	ORIG	2011-08-08
40045	ORIG	2011-08-05