Application 090060

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	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
A090060-001	FINASTERIDE	FINASTERIDE	1MG	TABLET / ORAL	AB		2013-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090060-001	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	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090060-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-07-01	`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	A090060-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090060-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090060-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090060-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090060-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090060-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090060-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090060-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090060-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090060-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090060-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090060-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090060-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090060-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090060-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090060-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090060-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090060-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090060-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090060-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090060-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090060-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090060-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090060-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090060-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090060-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090060-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090060-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090060-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090060-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090060-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090060-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090060-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090060-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090060-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090060-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090060-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090060-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090060-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090060-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Dr Reddys Laboratories Inc	9acbe693-8448-b443-9f78-1f9972520798	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090060 application number: ANDA090060 ndc (product): 43598-390
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	8f2626ef-66d9-6a77-e053-2995a90af056	2024-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090060 application number: ANDA090060 ndc (product): 68071-3094
Finasteride	FINASTERIDE	Asclemed USA, Inc.	b63af2cd-5c12-4977-bac4-95e1eae11e57	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090060 application number: ANDA090060 ndc (product): 76420-074
Finasteride	FINASTERIDE	Camber Pharmaceuticals, Inc.	00e934bb-c15b-490a-a852-839689a1231a	2017-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090060 application number: ANDA090060 ndc (product): 31722-526

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-526	Finasteride	Finasteride	Camber Pharmaceuticals, Inc.	ANDA	Current
43598-390	Finasteride	Finasteride	Dr Reddys Laboratories Inc	ANDA	Current
43598-390	Finasteride	Finasteride	Dr Reddys Laboratories Inc	ANDA	Current
50090-2160	Finasteride	Finasteride	A-S Medication Solutions	ANDA	Current
68071-3094	Finasteride	Finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3094	Finasteride	Finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68554-3026	Finasteride	Finasteride	Hetero Labs Limited	ANDA	Current
76420-074	Finasteride	Finasteride	Asclemed USA, Inc.	ANDA	Current
76420-074	Finasteride	Finasteride	Asclemed USA, Inc.	ANDA	Current