Application 204304

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	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
A204304-001	FINASTERIDE	FINASTERIDE	5MG	TABLET / ORAL	AB		2017-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204304-001	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	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`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	A204304-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204304-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204304-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204304-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204304-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204304-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204304-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204304-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204304-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204304-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204304-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204304-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204304-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204304-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204304-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204304-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204304-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204304-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204304-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204304-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204304-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204304-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204304-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204304-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204304-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204304-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204304-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204304-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204304-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204304-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204304-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204304-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204304-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204304-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204304-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204304-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204304-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204304-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204304-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204304-001	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Ascend Laboratories, LLC	9b38c8c7-01e4-45d0-b4ee-3546d9ad849c	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304 ndc (product): 67877-288
Finasteride	FINASTERIDE	REMEDYREPACK INC.	aa3fcd1a-02a1-49db-b40e-75e623d730e1	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	Direct_Rx	13673a09-8a50-5cd0-e063-6294a90a3d5b	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	Preferred Pharmaceuticals Inc.	33295dce-1e81-4187-bce1-d9b332ea062e	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	fe7e6ea7-583e-22d4-e053-6394a90a2526	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	Bryant Ranch Prepack	a7a3af01-de3f-4cd4-ba05-a41ca0544ac2	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304 ndc (product): 71335-1898
Finasteride	FINASTERIDE	A-S Medication Solutions	e6ee2f07-63a6-4fde-88de-654bf633529e	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	A-S Medication Solutions	5e69ea84-dc5a-4aac-9353-4920c6f7b3aa	2023-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304 ndc (product): 50090-4697
Finasteride	FINASTERIDE	Proficient Rx LP	e31a5901-ef04-4515-bca4-79118a3f3797	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	Aphena Pharma Solutions - Tennessee, LLC	845cad9c-c50d-4c98-8df8-893d1241836a	2022-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304 ndc (product): 71610-520

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4697	Finasteride	Finasteride	A-S Medication Solutions	ANDA	Current
50090-4697	Finasteride	Finasteride	A-S Medication Solutions	ANDA	Current
67877-288	Finasteride	Finasteride	Ascend Laboratories, LLC	ANDA	Current
67877-288	Finasteride	Finasteride	Ascend Laboratories, LLC	ANDA	Current
67877-288	Finasteride	Finasteride	Ascend Laboratories, LLC	ANDA	Current
67877-288	Finasteride	Finasteride	Ascend Laboratories, LLC	ANDA	Current
71335-1898	Finasteride	Finasteride	Bryant Ranch Prepack	ANDA	Current
71335-1898	Finasteride	Finasteride	Bryant Ranch Prepack	ANDA	Current
71610-520	Finasteride	Finasteride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-520	Finasteride	Finasteride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46839	ORIG	2017-01-13