Application 074249

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	CREAM;TOPICAL	0.05%	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
A074249-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1		1996-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074249-001	AB1

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	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074249-001	CLOBETASOL PROPIONATE	0.05%	CREAM / TOPICAL	AB1	1996-07-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074249-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074249-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074249-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074249-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074249-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074249-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074249-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074249-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074249-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074249-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074249-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074249-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074249-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074249-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074249-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074249-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074249-001	AB1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074249-001	AB1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074249-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074249-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074249-001	AB1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074249-001	AB1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074249-001	AB1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074249-001	AB1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074249-001	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074249-001	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074249-001	AB1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074249-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074249-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074249-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074249-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074249-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074249-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074249-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074249-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074249-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074249-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074249-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074249-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074249-001	AB1	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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	Sun Pharmaceutical Industries, Inc.	4a761afb-a48a-4a5a-8700-ad93601a260f	2026-03-23	Adverse reactions	Exact identifier application applno (ANDA): 074249 application number: ANDA074249 ndc (product): 51672-1258
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	ecef6314-97c0-4f2e-bbcb-53a62ac7fb72	2023-07-27	Adverse reactions	Exact identifier application applno (ANDA): 074249 application number: ANDA074249

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51672-1258	Clobetasol Propionate	Clobetasol Propionate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1258	Clobetasol Propionate	Clobetasol Propionate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
60429-902	Clobetasol Propionate	Clobetasol Propionate	Golden State Medical Supply, Inc.	ANDA	Current
60429-902	Clobetasol Propionate	Clobetasol Propionate	Golden State Medical Supply, Inc.	ANDA	Current
60429-902	Clobetasol Propionate	Clobetasol Propionate	Golden State Medical Supply, Inc.	ANDA	Current
60429-902	Clobetasol Propionate	Clobetasol Propionate	Golden State Medical Supply, Inc.	ANDA	Current
68071-4234	Clobetasol Propionate	Clobetasol Propionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9803	Clobetasol Propionate	Clobetasol Propionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
71085-007	Clobetasol Propionate	clobetasol propionate	IPG PHARMACEUTICALS, INC.	ANDA	Current