Application 076905

Type: ANDA
Sponsor: TEVA

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 44.

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
A076905-001	FINASTERIDE	FINASTERIDE	1MG	TABLET / ORAL			2013-11-05

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A076905-001	FINASTERIDE	1MG	TABLET / ORAL	2013-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076905-001	FINASTERIDE	1MG	TABLET / ORAL	2013-11-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076905-001	FINASTERIDE	1MG	TABLET / ORAL	2013-11-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076905-001	FINASTERIDE	1MG	TABLET / ORAL	2013-11-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076905-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076905-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076905-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076905-001	AB	1	`ea99ee380514…`

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 4 · 68 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Bryant Ranch Prepack	c9a3cb34-9a8e-4538-ab90-32e08d8acc3a	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	QUALLENT PHARMACEUTICALS HEALTH LLC	5efc695c-d9fd-4892-a63f-a35cceb8d3c7	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Bryant Ranch Prepack	a7a3af01-de3f-4cd4-ba05-a41ca0544ac2	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Rising Pharma Holdings, Inc.	9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	REMEDYREPACK INC.	aa3fcd1a-02a1-49db-b40e-75e623d730e1	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Major Pharmaceuticals	3272651f-b500-4d5d-9e29-22fcd8e24fcb	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	A-S Medication Solutions	7806f5d3-504a-4b6e-b566-22181f076d3f	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	A-S Medication Solutions	350b2bdb-84a1-4465-b0ad-175b8f720400	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Aurobindo Pharma Limited	32266029-c710-44dd-943f-7e31d0afa622	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Ascend Laboratories, LLC	9b38c8c7-01e4-45d0-b4ee-3546d9ad849c	2026-07-10	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	REMEDYREPACK INC.	90cc0d22-fa5c-4fe4-b0bf-554b715a05ac	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	REMEDYREPACK INC.	03429cec-c6b5-47fe-bb11-6b42f977df7e	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	REMEDYREPACK INC.	e482a50d-db15-4407-85c9-160c88e8a657	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Cardinal Health 107, LLC	3fec2bcb-91b8-4041-9ee8-e5a4ebe5fd04	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	NuCare Pharmaceuticals, Inc.	51286a03-c29c-2c0b-e063-6394a90af33c	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Coupler LLC	5087f6f2-92c0-3feb-e063-6394a90ab17d	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Cardinal Health 107, LLC	22161236-6804-4a7f-86cb-cfa20bd1951e	2026-04-27	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Preferred Pharmaceuticals Inc.	74b90430-8ce1-470c-939c-685ca9dfd74f	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	Preferred Pharmaceuticals, Inc.	9ae38bf5-17d7-4af1-922f-b3edb1e65392	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Finasteride generic name: FINASTERIDE
Finasteride	FINASTERIDE	A-S Medication Solutions	49eb3a1e-d7e6-4652-aa6d-6abf21af34a6	2026-03-26	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.