Application 077335

Type: ANDA
Sponsor: CIPLA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FINASTERIDE	FINASTERIDE	TABLET;ORAL	1MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077335-001	FINASTERIDE	FINASTERIDE	1MG	TABLET / ORAL			2014-11-20

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 2 · 43 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
2026-09-14 22:38:34	2026-08	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077335-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077335-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077335-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077335-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077335-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077335-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077335-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077335-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077335-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077335-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077335-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077335-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077335-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077335-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077335-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077335-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077335-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077335-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077335-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077335-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077335-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077335-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077335-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077335-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077335-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077335-001	AB	1	`cb3db0bc1861…`

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 2 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Preferred Pharmaceuticals, Inc.	9ae38bf5-17d7-4af1-922f-b3edb1e65392	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	REMEDYREPACK INC.	c2875bc7-e811-4860-9131-da06cecc2137	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	A-S Medication Solutions	49eb3a1e-d7e6-4652-aa6d-6abf21af34a6	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
PROSCAR	FINASTERIDE	Organon LLC	6f988153-fc74-4ca4-b29a-111f750c4a4b	2026-03-18	Warnings, Adverse reactions	Name fallback generic name: FINASTERIDE
Finasteride	FINASTERIDE	Legacy Pharmaceutical Packaging, LLC	a3b49681-09b3-4c26-bb57-3dfd598d48b6	2026-03-03	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	A-S Medication Solutions	2d726486-f9ef-49d1-b1ae-6b1c8650fa73	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Preferred Pharmaceuticals Inc.	cdde1382-a995-4f53-9497-7724d5e25b66	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Preferred Pharmaceuticals Inc.	b84a67d6-695e-4a7c-9b60-95e9ad18a501	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	AvPAK	800fa54c-c008-ba1e-e053-2a91aa0a2b07	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Direct_Rx	13673a09-8a50-5cd0-e063-6294a90a3d5b	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	NuCare Pharmaceuticals, Inc.	2c688ec5-1b0f-2269-e063-6394a90a7220	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Atlantic Biologicals Corps	29e59387-120c-4367-9f87-75cb53b6460d	2025-06-24	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Preferred Pharmaceuticals Inc.	33295dce-1e81-4187-bce1-d9b332ea062e	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Ascend Laboratories, LLC	ecd2fbb2-a4bd-44f2-831d-179e7dbf0741	2025-04-24	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	NCS HealthCare of KY, LLC dba Vangard Labs	8c3b1f6b-0010-4432-8eda-4af3c3573063	2025-02-19	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	fe7e6ea7-583e-22d4-e053-6394a90a2526	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	6360d8cc-72df-c571-e053-2991aa0a72c5	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Camber Pharmaceuticals, Inc.	cc9709ce-2d29-48bd-b46b-3f72114f2527	2025-01-24	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	fc9c4996-302c-2ad8-e053-6294a90a5f38	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	NuCare Pharmaceuticals, Inc.	291a2037-2b4f-a2fe-e063-6294a90a1e9a	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-112	Finasteride	Finasteride	Cipla USA Inc.	ANDA	Current