Application 207750

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A207750-001	FINASTERIDE	FINASTERIDE	1MG	TABLET / ORAL	AB		2017-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207750-001	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	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`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	A207750-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207750-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207750-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207750-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207750-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207750-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207750-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207750-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207750-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207750-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207750-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207750-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207750-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207750-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207750-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207750-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207750-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207750-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207750-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207750-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207750-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207750-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207750-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207750-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207750-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207750-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207750-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207750-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207750-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207750-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207750-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207750-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207750-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207750-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207750-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207750-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207750-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207750-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207750-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207750-001	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	REMEDYREPACK INC.	90cc0d22-fa5c-4fe4-b0bf-554b715a05ac	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750 ndc (product): 70518-2287
Finasteride	FINASTERIDE	A-S Medication Solutions	49eb3a1e-d7e6-4652-aa6d-6abf21af34a6	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750 ndc (product): 50090-4648
Finasteride	FINASTERIDE	Preferred Pharmaceuticals Inc.	b84a67d6-695e-4a7c-9b60-95e9ad18a501	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750 ndc (product): 68788-8275
Finasteride	FINASTERIDE	Ascend Laboratories, LLC	ecd2fbb2-a4bd-44f2-831d-179e7dbf0741	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750 ndc (product): 67877-455
Finasteride	FINASTERIDE	NuCare Pharmaceuticals, Inc.	291a2037-2b4f-a2fe-e063-6294a90a1e9a	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750
Finasteride	FINASTERIDE	Bryant Ranch Prepack	3e955ce4-d44e-4b4d-b763-ab141cb3f06d	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750 ndc (product): 71335-1304
Finasteride	FINASTERIDE	Proficient Rx LP	196f7d23-ed90-46c2-ae34-615e6ec1650b	2023-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750
Finasteride	FINASTERIDE	Thirty Madison Inc	3fe7bdaa-b027-4da9-94ee-550bf28c63e1	2021-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750 ndc (product): 71713-099

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4648	Finasteride	Finasteride	A-S Medication Solutions	ANDA	Current
50436-0455	Finasteride	Finasteride	Unit Dose Services	ANDA	Current
67877-455	Finasteride	Finasteride	Ascend Laboratories, LLC	ANDA	Current
67877-455	Finasteride	Finasteride	Ascend Laboratories, LLC	ANDA	Current
67877-455	Finasteride	Finasteride	Ascend Laboratories, LLC	ANDA	Current
68071-2620	Finasteride	Finasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8275	Finasteride	Finasteride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2287	Finasteride	Finasteride	REMEDYREPACK INC.	ANDA	Current
70518-2287	Finasteride	Finasteride	REMEDYREPACK INC.	ANDA	Current
70518-2287	Finasteride	Finasteride	REMEDYREPACK INC.	ANDA	Current
70518-2287	Finasteride	Finasteride	REMEDYREPACK INC.	ANDA	Current
71335-1304	Finasteride	Finasteride	Bryant Ranch Prepack	ANDA	Current
71335-1304	Finasteride	Finasteride	Bryant Ranch Prepack	ANDA	Current
71335-1304	Finasteride	Finasteride	Bryant Ranch Prepack	ANDA	Current
71713-099	Finasteride	Finasteride	Thirty Madison Inc	ANDA	Current