Application 091643

Type: ANDA
Sponsor: ACCORD HLTHCARE

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 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
A091643-001	FINASTERIDE	FINASTERIDE	1MG	TABLET / ORAL	AB		2013-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091643-001	AB

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	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A091643-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091643-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091643-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091643-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091643-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091643-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091643-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091643-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091643-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091643-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091643-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091643-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091643-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091643-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091643-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091643-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091643-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091643-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091643-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091643-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091643-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091643-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091643-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091643-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091643-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091643-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091643-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091643-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091643-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091643-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091643-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091643-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091643-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091643-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091643-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091643-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091643-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091643-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091643-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091643-001	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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Accord Healthcare, Inc.	e3728709-e805-4b46-9954-2c433a865987	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091643 application number: ANDA091643 ndc (product): 16729-089
Finasteride	FINASTERIDE	Proficient Rx LP	870ab7fe-fff9-4348-b900-213c1cf05f8e	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091643 application number: ANDA091643 ndc (product): 63187-863

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
16729-089	Finasteride	Finasteride	Accord Healthcare, Inc.	ANDA	Current
16729-089	Finasteride	Finasteride	Accord Healthcare, Inc.	ANDA	Current
16729-089	Finasteride	Finasteride	Accord Healthcare, Inc.	ANDA	Current
16729-089	Finasteride	Finasteride	Accord Healthcare, Inc.	ANDA	Current
50090-3942	Finasteride	Finasteride	A-S Medication Solutions	ANDA	Current
50090-3942	Finasteride	Finasteride	A-S Medication Solutions	ANDA	Current
50436-0089	Finasteride	Finasteride	Unit Dose Services	ANDA	Current
63187-863	Finasteride	Finasteride	Proficient Rx LP	ANDA	Current
63187-863	Finasteride	Finasteride	Proficient Rx LP	ANDA	Current
63187-863	Finasteride	Finasteride	Proficient Rx LP	ANDA	Current
63187-863	Finasteride	Finasteride	Proficient Rx LP	ANDA	Current
63187-863	Finasteride	Finasteride	Proficient Rx LP	ANDA	Current
63187-863	Finasteride	Finasteride	Proficient Rx LP	ANDA	Current
68071-4167	Finasteride	Finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4167	Finasteride	Finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4167	Finasteride	Finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4541	Finasteride	Finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4541	Finasteride	Finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9249	Finasteride	Finasteride	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-0235	Finasteride	Finasteride	Bryant Ranch Prepack	ANDA	Current
71335-0235	Finasteride	Finasteride	Bryant Ranch Prepack	ANDA	Current
71713-096	Finasteride	Finasteride	Thirty Madison Inc	ANDA	Current
71713-096	Finasteride	Finasteride	Thirty Madison Inc	ANDA	Current
76519-1204	FINASTERIDE	FINASTERIDE	H.J. Harkins Company, Inc.	ANDA	Current