Application 077914

Type: ANDA
Sponsor: ACTAVIS TOTOWA TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FINASTERIDE	FINASTERIDE	TABLET;ORAL	5MG	No	No

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

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
A077914-001	FINASTERIDE	FINASTERIDE	5MG	TABLET / ORAL			2007-03-28

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 · 41 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	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077914-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077914-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077914-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077914-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077914-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077914-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077914-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077914-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077914-001	FINASTERIDE	5MG	TABLET / ORAL		2007-03-28	`cb3db0bc1861…`

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	A077914-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077914-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077914-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077914-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077914-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077914-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077914-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077914-001	AB	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 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Ascend Laboratories, LLC	9b38c8c7-01e4-45d0-b4ee-3546d9ad849c	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	REMEDYREPACK INC.	90cc0d22-fa5c-4fe4-b0bf-554b715a05ac	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	REMEDYREPACK INC.	da4e8a51-cf1c-4018-976f-edecc4934a39	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	REMEDYREPACK INC.	aa3fcd1a-02a1-49db-b40e-75e623d730e1	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	REMEDYREPACK INC.	03429cec-c6b5-47fe-bb11-6b42f977df7e	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	REMEDYREPACK INC.	e482a50d-db15-4407-85c9-160c88e8a657	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Cardinal Health 107, LLC	3fec2bcb-91b8-4041-9ee8-e5a4ebe5fd04	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Bryant Ranch Prepack	c9a3cb34-9a8e-4538-ab90-32e08d8acc3a	2026-05-08	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Aurobindo Pharma Limited	32266029-c710-44dd-943f-7e31d0afa622	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	NuCare Pharmaceuticals, Inc.	51286a03-c29c-2c0b-e063-6394a90af33c	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Teva Pharmaceuticals USA, Inc.	77589cc3-c440-4695-800c-82a0e5128a6c	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Coupler LLC	5087f6f2-92c0-3feb-e063-6394a90ab17d	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Cardinal Health 107, LLC	22161236-6804-4a7f-86cb-cfa20bd1951e	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Preferred Pharmaceuticals Inc.	74b90430-8ce1-470c-939c-685ca9dfd74f	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
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

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
45963-500	Finasteride	Finasteride	Actavis Pharma, Inc.	ANDA	Current
45963-500	Finasteride	Finasteride	Actavis Pharma, Inc.	ANDA	Current
50268-323	Finasteride	Finasteride	AvPAK	ANDA	Current
50268-323	Finasteride	Finasteride	AvPAK	ANDA	Current
63739-495	Finasteride	Finasteride	McKesson Packaging Services Business Unit of McKesson Corporation	ANDA	Current
68084-399	Finasteride	Finasteride	American Health Packaging	ANDA	Current