Application 091365

Type: ANDA
Sponsor: DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MG BASE/VIAL	No	No
002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091365-001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP		2011-07-25
A091365-002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2011-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091365-001	AP
A091365-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091365-001	GEMCITABINE HYDROCHLORIDE	EQ 200MG BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091365-002	GEMCITABINE HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2011-07-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091365-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091365-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091365-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091365-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091365-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091365-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091365-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091365-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091365-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091365-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091365-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091365-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091365-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091365-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091365-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091365-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091365-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091365-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091365-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091365-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091365-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091365-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091365-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091365-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091365-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091365-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091365-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091365-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091365-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091365-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091365-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091365-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091365-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091365-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091365-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091365-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091365-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091365-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091365-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091365-002	AP	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GEMCITABINE	GEMCITABINE HYDROCHLORIDE	NorthStar Rx LLC	5af49a48-f1c0-467d-b5da-ac9f1ae8e34c	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091365 application number: ANDA091365 ndc (product): 16714-930 ndc (product): 16714-909
GEMCITABINE	GEMCITABINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	a5949d02-29eb-4626-ad35-b7614bb0fa95	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091365 application number: ANDA091365 ndc (product): 71288-113 ndc (product): 71288-114
gemcitabine	GEMCITABINE	Dr. Reddy's Laboratories Limited	eafcebc8-ddef-bb6b-fd0a-9d8b9962cdc4	2024-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091365 application number: ANDA091365 ndc (product): 55111-686 ndc (product): 55111-687

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-909	GEMCITABINE	GEMCITABINE HYDROCHLORIDE	NorthStar Rx LLC	ANDA	Current
16714-909	GEMCITABINE	GEMCITABINE HYDROCHLORIDE	NorthStar Rx LLC	ANDA	Current
16714-930	GEMCITABINE	GEMCITABINE HYDROCHLORIDE	NorthStar Rx LLC	ANDA	Current
16714-930	GEMCITABINE	GEMCITABINE HYDROCHLORIDE	NorthStar Rx LLC	ANDA	Current
55111-686	gemcitabine	Gemcitabine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-686	gemcitabine	gemcitabine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-687	gemcitabine	Gemcitabine	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-687	gemcitabine	gemcitabine	Dr. Reddy's Laboratories Limited	ANDA	Current
55390-391	gemcitabine	gemcitabine	Bedford Laboratories	ANDA	Current
71288-113	GEMCITABINE	GEMCITABINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-113	GEMCITABINE	GEMCITABINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-114	GEMCITABINE	GEMCITABINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-114	GEMCITABINE	GEMCITABINE HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	ANDA	Current