Application 204549

Type: ANDA
Sponsor: ACTAVIS 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)	No	No
002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	1GM/26.3ML (38MG/ML)	No	No
003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	2GM/52.6ML (38MG/ML)	No	No

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	Approval date
A204549-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11
A204549-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11
A204549-003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204549-002	GEMCITABINE HYDROCHLORIDE	1GM/26.3ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204549-003	GEMCITABINE HYDROCHLORIDE	2GM/52.6ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204549-001	GEMCITABINE HYDROCHLORIDE	200MG/5.26ML (38MG/ML)	INJECTABLE / INJECTION	2016-04-11	`1e350fbaab3a…`

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	A204549-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204549-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204549-003	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204549-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204549-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204549-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204549-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204549-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204549-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204549-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204549-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204549-003	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 brand name: Gemcitabine hydrochloride 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 brand name: gemcitabine hydrochloride 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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45963-623	Gemcitabine	Gemcitabine	Actavis Pharma, Inc.	ANDA	Current
45963-623	Gemcitabine	Gemcitabine	Actavis Pharma, Inc.	ANDA	Current
45963-623	Gemcitabine	Gemcitabine	Actavis Pharma, Inc.	ANDA	Current
45963-623	Gemcitabine	Gemcitabine	Actavis Pharma, Inc.	ANDA	Current
45963-624	Gemcitabine	Gemcitabine	Actavis Pharma, Inc.	ANDA	Current
45963-624	Gemcitabine	Gemcitabine	Actavis Pharma, Inc.	ANDA	Current
45963-624	Gemcitabine	Gemcitabine	Actavis Pharma, Inc.	ANDA	Current
45963-624	Gemcitabine	Gemcitabine	Actavis Pharma, Inc.	ANDA	Current
45963-636	Gemcitabine	Gemcitabine	Actavis Pharma, Inc.	ANDA	Current
45963-636	Gemcitabine	Gemcitabine	Actavis Pharma, Inc.	ANDA	Current
45963-636	Gemcitabine	Gemcitabine	Actavis Pharma, Inc.	ANDA	Current
45963-636	Gemcitabine	Gemcitabine	Actavis Pharma, Inc.	ANDA	Current