Application 206574

Type: ANDA
Sponsor: ASCENT PHARMS 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 42.

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
A206574-001	DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB		2016-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206574-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206574-001	DUTASTERIDE	0.5MG	CAPSULE / ORAL	AB	2016-10-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206574-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206574-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206574-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206574-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206574-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206574-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206574-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206574-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206574-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206574-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206574-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206574-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206574-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206574-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206574-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206574-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206574-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206574-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206574-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206574-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206574-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206574-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206574-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206574-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206574-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206574-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206574-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206574-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206574-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206574-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206574-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206574-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206574-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206574-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206574-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206574-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206574-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206574-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206574-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206574-001	AB	1	`e64feba35796…`

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
Dutasteride	DUTASTERIDE	Bryant Ranch Prepack	170f01fe-5048-413c-b4cd-8311e1a2728a	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574 ndc (product): 63629-8207
Dutasteride	DUTASTERIDE	Bryant Ranch Prepack	50924a17-b21d-40ca-b702-aa61bac7af90	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574 ndc (product): 63629-1223
Dutasteride	DUTASTERIDE	Bryant Ranch Prepack	74f29982-2317-4d31-a324-fe99bd134c31	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574 ndc (product): 63629-1222
Dutasteride	DUTASTERIDE	A-S Medication Solutions	af5e7d42-6953-4b7f-afac-257e9444b0a2	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574 ndc (product): 50090-4010
Dutasteride	DUTASTERIDE	Bryant Ranch Prepack	3285b390-f531-4e99-9bae-828ac66e874d	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574
Dutasteride	DUTASTERIDE	NuCare Pharmaceuticals, Inc.	28519a08-3bf8-98b9-e063-6394a90a03f7	2024-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574
Dutasteride	DUTASTERIDE	Proficient Rx LP	908832b2-21d6-48ae-89cb-f06687321f74	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574 ndc (product): 71205-278
Dutasteride	DUTASTERIDE	NuCare Pharmaceuticals,Inc.	85023ea5-af64-4b91-e053-2991aa0a3373	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574 ndc (product): 68071-4821
Dutasteride	DUTASTERIDE	XLCare Pharmaceuticals, Inc.	40ddf119-b0a5-4375-9285-d50a24ed1532	2021-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574 ndc (product): 72865-140
Dutasteride	DUTASTERIDE	Camber Pharmaceuticals, Inc.	6b6f8d1b-1759-4fbb-9b95-c20db803e1c2	2021-09-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206574 application number: ANDA206574 ndc (product): 31722-131

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-131	Dutasteride	Dutasteride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-131	Dutasteride	Dutasteride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-131	Dutasteride	Dutasteride	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-4010	Dutasteride	Dutasteride	A-S Medication Solutions	ANDA	Current
50090-4010	Dutasteride	Dutasteride	A-S Medication Solutions	ANDA	Current
50268-282	Dutasteride	Dutasteride	AvPAK	ANDA	Current
51407-157	Dutasteride	Dutasteride	Golden State Medical Supply Inc.	ANDA	Current
51407-157	Dutasteride	Dutasteride	Golden State Medical Supply Inc.	ANDA	Current
51407-157	Dutasteride	Dutasteride	Golden State Medical Supply Inc.	ANDA	Current
51407-157	Dutasteride	Dutasteride	Golden State Medical Supply Inc.	ANDA	Current
51407-157	Dutasteride	Dutasteride	Golden State Medical Supply, Inc.	ANDA	Current
51407-157	Dutasteride	Dutasteride	Golden State Medical Supply, Inc.	ANDA	Current
63629-1222	Dutasteride	Dutasteride	Bryant Ranch Prepack	ANDA	Current
63629-1222	Dutasteride	Dutasteride	Bryant Ranch Prepack	ANDA	Current
63629-1222	Dutasteride	Dutasteride	Bryant Ranch Prepack	ANDA	Current
63629-1223	Dutasteride	Dutasteride	Bryant Ranch Prepack	ANDA	Current
63629-1223	Dutasteride	Dutasteride	Bryant Ranch Prepack	ANDA	Current
63629-1223	Dutasteride	Dutasteride	Bryant Ranch Prepack	ANDA	Current
63629-8207	Dutasteride	Dutasteride	Bryant Ranch Prepack	ANDA	Current
63629-8207	Dutasteride	Dutasteride	Bryant Ranch Prepack	ANDA	Current
63629-8207	Dutasteride	Dutasteride	Bryant Ranch Prepack	ANDA	Current
63629-8207	Dutasteride	Dutasteride	Bryant Ranch Prepack	ANDA	Current
68071-2610	Dutasteride	Dutasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4821	Dutasteride	Dutasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4821	Dutasteride	Dutasteride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2378	Dutasteride	Dutasteride	REMEDYREPACK INC.	ANDA	Current
70518-2378	Dutasteride	Dutasteride	REMEDYREPACK INC.	ANDA	Current
70518-2378	Dutasteride	Dutasteride	REMEDYREPACK INC.	ANDA	Current
70518-2378	Dutasteride	Dutasteride	REMEDYREPACK INC.	ANDA	Current
71205-278	Dutasteride	Dutasteride	Proficient Rx LP	ANDA	Current
71205-278	Dutasteride	Dutasteride	Proficient Rx LP	ANDA	Current
71205-278	Dutasteride	Dutasteride	Proficient Rx LP	ANDA	Current
71205-278	Dutasteride	Dutasteride	Proficient Rx LP	ANDA	Current
72865-140	Dutasteride	Dutasteride	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-140	Dutasteride	Dutasteride	XLCare Pharmaceuticals, Inc.	ANDA	Current
72865-140	Dutasteride	Dutasteride	XLCare Pharmaceuticals, Inc.	ANDA	Current