Application 076493

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	LOTION;TOPICAL	EQ 0.05% BASE;1%	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
A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076493-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB		2004-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB		2004-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB		2004-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB		2004-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB		2004-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB		2004-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB		2004-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076493-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	RS	2004-07-28	`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	A076493-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076493-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076493-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076493-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076493-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076493-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076493-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076493-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076493-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076493-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076493-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076493-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076493-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076493-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076493-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076493-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076493-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076493-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076493-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076493-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076493-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076493-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076493-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076493-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076493-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076493-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076493-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076493-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076493-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076493-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076493-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076493-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076493-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076493-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076493-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076493-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076493-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076493-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076493-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076493-001	AB	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Sun Pharmaceutical Industries, Inc.	e4e9f244-4a85-4c0d-9917-93182c4a6e87	2025-07-07	Adverse reactions	Exact identifier application applno (ANDA): 076493 application number: ANDA076493 ndc (product): 51672-1308

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
51672-1308	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31130	ORIG	2004-07-30