Application 202808

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DUTASTERIDE	DUTASTERIDE	CAPSULE;ORAL	0.5MG	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
A202808-001	DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE / ORAL			2015-11-20

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A202808-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	2015-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202808-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	2015-11-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202808-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	2015-11-20	`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	A202808-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A202808-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202808-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202808-001	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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dutasteride	DUTASTERIDE	Strides Pharma Science Limited	c78d18cf-05df-4154-b2f9-39cc374ca9e3	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	Bryant Ranch Prepack	170f01fe-5048-413c-b4cd-8311e1a2728a	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
DUTASTERIDE	DUTASTERIDE	Banyan Pharma LLC	947644ea-bc35-41df-8a7a-874360c90192	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: DUTASTERIDE generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	Bryant Ranch Prepack	50924a17-b21d-40ca-b702-aa61bac7af90	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	Bryant Ranch Prepack	74f29982-2317-4d31-a324-fe99bd134c31	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	A-S Medication Solutions	af338f55-55c1-4034-9c27-c3564addf24e	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	A-S Medication Solutions	af5e7d42-6953-4b7f-afac-257e9444b0a2	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	Bryant Ranch Prepack	3285b390-f531-4e99-9bae-828ac66e874d	2025-10-01	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	Aurobindo Pharma Limited	b32611f3-50ec-45bb-a671-ea10cec7829d	2025-09-11	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	NuCare Pharmaceuticals, Inc.	369f73b9-e032-4315-e063-6294a90a4ca1	2025-06-02	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	Epic Pharma, LLC	2ee1eef5-8ec7-46c1-b4fa-13184915448f	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	NuCare Pharmaceuticals, Inc.	2ad309b1-4497-8b9b-e063-6394a90aa9b4	2025-01-03	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	NuCare Pharmaceuticals, Inc.	28519a08-3bf8-98b9-e063-6394a90a03f7	2024-12-02	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	A-S Medication Solutions	468df1b8-1f82-4328-a549-0a716ad1266d	2024-10-21	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	Proficient Rx LP	908832b2-21d6-48ae-89cb-f06687321f74	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	NuCare Pharmaceuticals,Inc.	85023ea5-af64-4b91-e053-2991aa0a3373	2024-08-13	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	MARKSANS PHARMA LIMITED	c4bc56a1-e31c-44fb-bfb5-f77425ff1ea1	2024-07-22	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	Amneal Pharmaceuticals LLC	e537c60d-9ba2-4e7f-a405-2b915dcd7ead	2023-08-24	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	XLCare Pharmaceuticals, Inc.	40ddf119-b0a5-4375-9285-d50a24ed1532	2021-09-27	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE
Dutasteride	DUTASTERIDE	Camber Pharmaceuticals, Inc.	6b6f8d1b-1759-4fbb-9b95-c20db803e1c2	2021-09-20	Warnings, Adverse reactions	Name fallback brand name: Dutasteride generic name: DUTASTERIDE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2292	Dutasteride	Dutasteride	Actavis Pharma, Inc.	ANDA	Current
63187-657	Dutasteride	Dutasteride	Proficient Rx LP	ANDA	Current