Application 090061

Type: ANDA
Sponsor: HETERO LABS LTD III

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 42.

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
A090061-001	FINASTERIDE	FINASTERIDE	5MG	TABLET / ORAL	AB		2010-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090061-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090061-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090061-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090061-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090061-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090061-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090061-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090061-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090061-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090061-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090061-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090061-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090061-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090061-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090061-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090061-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090061-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090061-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090061-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090061-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090061-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090061-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090061-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090061-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090061-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090061-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090061-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090061-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090061-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090061-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090061-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090061-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090061-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090061-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090061-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090061-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090061-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090061-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090061-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090061-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090061-001	AB	1	`e64feba35796…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Cardinal Health 107, LLC	3fec2bcb-91b8-4041-9ee8-e5a4ebe5fd04	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061 ndc (product): 55154-8083
Finasteride	FINASTERIDE	Cardinal Health 107, LLC	22161236-6804-4a7f-86cb-cfa20bd1951e	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Preferred Pharmaceuticals, Inc.	9ae38bf5-17d7-4af1-922f-b3edb1e65392	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	REMEDYREPACK INC.	c2875bc7-e811-4860-9131-da06cecc2137	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061 ndc (product): 70518-3182
Finasteride	FINASTERIDE	Legacy Pharmaceutical Packaging, LLC	a3b49681-09b3-4c26-bb57-3dfd598d48b6	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061 ndc (product): 68645-541
Finasteride	FINASTERIDE	A-S Medication Solutions	2d726486-f9ef-49d1-b1ae-6b1c8650fa73	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061 ndc (product): 50090-1936
Finasteride	FINASTERIDE	AvPAK	800fa54c-c008-ba1e-e053-2a91aa0a2b07	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061 ndc (product): 50268-314
Finasteride	FINASTERIDE	Major Pharmaceuticals	3272651f-b500-4d5d-9e29-22fcd8e24fcb	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061 ndc (product): 0904-6830
Finasteride	FINASTERIDE	Camber Pharmaceuticals, Inc.	cc9709ce-2d29-48bd-b46b-3f72114f2527	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061 ndc (product): 31722-525
Finasteride	FINASTERIDE	Dr Reddys Laboratories Inc	c8ed59a3-c5b2-3156-b781-5e514b79011b	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061 ndc (product): 43598-303
Finasteride	FINASTERIDE	A-S Medication Solutions	d66fe4bd-534b-4674-a346-0cf3cdabbfaa	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Aphena Pharma Solutions - Tennessee, LLC	57e73fff-2115-41ad-864b-4652f9fd4545	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061 ndc (product): 71610-515
Finasteride	FINASTERIDE	Exelan Pharmaceuticals Inc.	1c1bf77c-f99a-44e4-b71e-ce766afa99b6	2020-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061 ndc (product): 76282-412

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0179-0175	Finasteride	Finasteride	KAISER FOUNDATION HOSPITALS	ANDA	Current
0904-6830	Finasteride	Finasteride	Major Pharmaceuticals	ANDA	Current
0904-6830	Finasteride	Finasteride	Major Pharmaceuticals	ANDA	Current
0904-6830	Finasteride	Finasteride	Major Pharmaceuticals	ANDA	Current
0904-6830	Finasteride	Finasteride	Major Pharmaceuticals	ANDA	Current
31722-525	Finasteride	Finasteride	Camber Pharmaceuticals, Inc.	ANDA	Current
33261-833	Finasteride	Finasteride	Aidarex Pharmaceuticals LLC	ANDA	Current
43598-303	Finasteride	Finasteride	Dr Reddys Laboratories Inc	ANDA	Current
43598-303	Finasteride	Finasteride	Dr Reddys Laboratories Inc	ANDA	Current
50090-1936	Finasteride	Finasteride	A-S Medication Solutions	ANDA	Current
50090-1936	Finasteride	Finasteride	A-S Medication Solutions	ANDA	Current
50090-1936	Finasteride	Finasteride	A-S Medication Solutions	ANDA	Current
50268-314	Finasteride	Finasteride	AvPAK	ANDA	Current
50268-314	Finasteride	Finasteride	AvPAK	ANDA	Current
50268-314	Finasteride	Finasteride	AvPAK	ANDA	Current
50268-314	Finasteride	Finasteride	AvPAK	ANDA	Current
55154-8083	Finasteride	Finasteride	Cardinal Health	ANDA	Current
55154-8083	Finasteride	Finasteride	Cardinal Health	ANDA	Current
55154-8083	Finasteride	Finasteride	Cardinal Health	ANDA	Current
65977-5025	Finasteride	Finasteride	Hetero Drugs Limited	ANDA	Current
68071-2695	Finasteride	Finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68554-3025	Finasteride	Finasteride	Hetero Labs Limited	ANDA	Current
68645-541	Finasteride	Finasteride	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-541	Finasteride	Finasteride	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-541	Finasteride	Finasteride	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68645-541	Finasteride	Finasteride	Legacy Pharmaceutical Packaging, LLC	ANDA	Current
68788-9519	Finasteride	Finasteride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9519	Finasteride	Finasteride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-3182	Finasteride	Finasteride	REMEDYREPACK INC.	ANDA	Current
71610-515	Finasteride	Finasteride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76282-412	Finasteride	Finasteride	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-412	Finasteride	Finasteride	Exelan Pharmaceuticals Inc.	ANDA	Current