Application 090121

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	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
A090121-001	FINASTERIDE	FINASTERIDE	5MG	TABLET / ORAL	AB		2010-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090121-001	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	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`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	A090121-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090121-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090121-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090121-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090121-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090121-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090121-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090121-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090121-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090121-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090121-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090121-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090121-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090121-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090121-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090121-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090121-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090121-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090121-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090121-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090121-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090121-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090121-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090121-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090121-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090121-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090121-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090121-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090121-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090121-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090121-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090121-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090121-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090121-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090121-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090121-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090121-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090121-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090121-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090121-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Atlantic Biologicals Corps	29e59387-120c-4367-9f87-75cb53b6460d	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121 ndc (product): 17856-0090
Finasteride	FINASTERIDE	Bryant Ranch Prepack	ef9c0b23-4736-4fb0-862c-c2a4d644e0d6	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121 ndc (product): 71335-0433
Finasteride	FINASTERIDE	Accord Healthcare, Inc.	adfb8f6b-a7bb-4ac2-b2aa-fec6d56630ad	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121 ndc (product): 16729-090
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	54c73290-bdc1-3453-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121 ndc (product): 68071-3354
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	549aab5d-819a-1691-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121 ndc (product): 68071-3380
Finasteride	FINASTERIDE	Proficient Rx LP	e9ea2f77-11c3-4dbf-bdc4-d1b0e7437990	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121 ndc (product): 63187-265
Finasteride	FINASTERIDE	Bryant Ranch Prepack	88511bd5-624e-49d6-b80e-1f1d47314fb6	2020-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121 ndc (product): 71335-1634

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-090	Finasteride	finasteride	Accord Healthcare, Inc.	ANDA	Current
16729-090	Finasteride	finasteride	Accord Healthcare, Inc.	ANDA	Current
17856-0090	Finasteride	finasteride	Atlantic Biologicals Corps	ANDA	Current
17856-0090	Finasteride	finasteride	Atlantic Biologicals Corps	ANDA	Current
17856-0090	Finasteride	finasteride	Atlantic Biologicals Corp	ANDA	Current
50090-1718	Finasteride	finasteride	A-S Medication Solutions	ANDA	Current
50090-1718	Finasteride	finasteride	A-S Medication Solutions	ANDA	Current
50090-1718	Finasteride	finasteride	A-S Medication Solutions	ANDA	Current
58517-200	Finasteride	Finasteride	New Horizon Rx Group, LLC	ANDA	Current
61919-733	Finasteride	Finasteride	Direct_Rx	ANDA	Current
63187-265	Finasteride	finasteride	Proficient Rx LP	ANDA	Current
63187-265	Finasteride	finasteride	Proficient Rx LP	ANDA	Current
63187-265	Finasteride	finasteride	Proficient Rx LP	ANDA	Current
63187-265	Finasteride	finasteride	Proficient Rx LP	ANDA	Current
63187-265	Finasteride	finasteride	Proficient Rx LP	ANDA	Current
63629-8180	Finasteride	finasteride	Bryant Ranch Prepack	ANDA	Current
67046-695	Finasteride	Finasteride	Contract Pharmacy Services-PA	ANDA	Current
68071-3306	Finasteride	finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3306	Finasteride	finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3306	Finasteride	finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3354	Finasteride	finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3354	Finasteride	finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3354	Finasteride	finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3380	Finasteride	finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3380	Finasteride	finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3380	Finasteride	finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4044	Finasteride	finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6976	Finasteride	finasteride	Preferred Pharmacetucals Inc.	ANDA	Current
68788-6976	Finasteride	finasteride	Preferred Pharmacetucals Inc.	ANDA	Current
68788-6976	Finasteride	finasteride	Preferred Pharmacetucals Inc.	ANDA	Current
68788-6976	Finasteride	finasteride	Preferred Pharmacetucals Inc.	ANDA	Current
68788-6976	Finasteride	finasteride	Preferred Pharmacetucals Inc.	ANDA	Current
70518-0397	Finasteride	finasteride	REMEDYREPACK INC.	ANDA	Current
70518-0397	Finasteride	finasteride	REMEDYREPACK INC.	ANDA	Current
70518-0397	Finasteride	finasteride	REMEDYREPACK INC.	ANDA	Current
70518-0397	Finasteride	finasteride	REMEDYREPACK INC.	ANDA	Current
70518-0397	Finasteride	finasteride	REMEDYREPACK INC.	ANDA	Current
70518-2363	Finasteride	finasteride	REMEDYREPACK INC.	ANDA	Current
70518-2363	Finasteride	finasteride	REMEDYREPACK INC.	ANDA	Current
70518-2363	Finasteride	finasteride	REMEDYREPACK INC.	ANDA	Current
70518-2363	Finasteride	finasteride	REMEDYREPACK INC.	ANDA	Current
70518-2363	Finasteride	finasteride	REMEDYREPACK INC.	ANDA	Current
70518-2363	Finasteride	finasteride	REMEDYREPACK INC.	ANDA	Current
71335-0433	Finasteride	finasteride	Bryant Ranch Prepack	ANDA	Current
71335-0433	Finasteride	finasteride	Bryant Ranch Prepack	ANDA	Current
71335-1634	Finasteride	finasteride	Bryant Ranch Prepack	ANDA	Current