Application 202975

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	CAPSULE;ORAL	0.5MG;0.4MG	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
A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	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 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	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2015-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2015-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2015-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2015-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL	AB	2015-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202975-001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE / ORAL		2015-11-20	`cb3db0bc1861…`

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	A202975-001	AB	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A202975-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202975-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202975-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202975-001	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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dutasteride and tamsulosin hydrochloride	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	Zydus Lifesciences Limited	4b89b07e-9d19-47a2-bd53-bc5eef9deed1	2024-11-28		Name fallback brand name: Dutasteride and tamsulosin hydrochloride
Dutasteride and tamsulosin hydrochloride	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	d6557691-7910-4006-9268-410583e437d1	2024-11-11	Warnings, Adverse reactions	Name fallback brand name: Dutasteride and tamsulosin hydrochloride
Dutasteride and Tamsulosin Hydrochloride	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	Aurobindo Pharma Limited	2ad47033-76f3-447d-8a44-21479e9164c0	2024-07-19	Warnings, Adverse reactions	Name fallback brand name: Dutasteride and Tamsulosin Hydrochloride

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
0591-3771	Dutasteride and tamsulosin hydrochloride	Dutasteride and tamsulosin hydrochloride	Actavis Pharma, Inc.	ANDA	Current