Application 077335

Type: ANDA
Sponsor: CIPLA

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 43.

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
A077335-001	FINASTERIDE	FINASTERIDE	1MG	TABLET / ORAL			2014-11-20

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 · 43 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
2026-09-14 22:38:34	2026-08	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077335-001	FINASTERIDE	1MG	TABLET / ORAL		2014-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077335-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2014-11-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077335-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077335-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077335-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077335-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077335-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077335-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077335-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077335-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077335-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077335-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077335-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077335-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077335-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077335-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077335-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077335-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077335-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077335-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077335-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077335-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077335-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077335-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077335-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077335-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077335-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077335-001	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 3 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Dr. Reddy's Laboratories Limited	fa19372d-027d-a91b-f58e-1bdb8fd7e2b6	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Bryant Ranch Prepack	ef9c0b23-4736-4fb0-862c-c2a4d644e0d6	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
PROPECIA	FINASTERIDE	Organon LLC	6f904709-65aa-44ce-b144-b4c8a0416e36	2024-10-14	Warnings, Adverse reactions	Name fallback generic name: FINASTERIDE
Finasteride	FINASTERIDE	Accord Healthcare, Inc.	e3728709-e805-4b46-9954-2c433a865987	2024-10-03	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	American Health Packaging	8f468081-254a-4f11-9f0b-c0311e353a50	2024-09-18	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	A-S Medication Solutions	d66fe4bd-534b-4674-a346-0cf3cdabbfaa	2024-08-26	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Bryant Ranch Prepack	3e955ce4-d44e-4b4d-b763-ab141cb3f06d	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	8f2626ef-66d9-6a77-e053-2995a90af056	2024-07-19	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	54c73290-bdc1-3453-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	549aab5d-819a-1691-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	8488cd17-365c-701c-e053-2991aa0af5f9	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Bryant Ranch Prepack	61e6cbb8-ddd2-4e07-b182-6348f216858b	2024-05-20	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	A-S Medication Solutions	e6ee2f07-63a6-4fde-88de-654bf633529e	2024-05-15	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Burel Pharmaceuticals, LLC	c8516eaa-98d0-4eb1-bc65-aa765baea5db	2024-04-25	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Rising Pharma Holdings, Inc.	01b88593-99d3-4dd6-a7b6-5438c15bd7b7	2024-04-19	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Aurobindo Pharma Limited	7d140366-2388-488e-bd86-67e6edf44345	2024-04-19	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Aphena Pharma Solutions - Tennessee, LLC	57e73fff-2115-41ad-864b-4652f9fd4545	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	A-S Medication Solutions	5e69ea84-dc5a-4aac-9353-4920c6f7b3aa	2023-08-10	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Dr. Reddy's Laboratories Limited	a4dd6d6c-c8c7-16a9-aa68-aa46283dfae1	2023-07-20	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Proficient Rx LP	196f7d23-ed90-46c2-ae34-615e6ec1650b	2023-04-01	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-112	Finasteride	Finasteride	Cipla USA Inc.	ANDA	Current