Application 076516

Type: ANDA
Sponsor: FOUGERA PHARMS

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 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
A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB		2005-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076516-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076516-001	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE;1%	LOTION / TOPICAL	AB	2005-06-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A076516-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076516-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076516-001	AB	1	`a50c72e98297…`

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 · 20 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	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	55db730a-df6d-4950-9c26-91b06bdcef36	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	REMEDYREPACK INC.	5c064fc8-0426-4608-90ee-93609a7e5547	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Redpharm Drug	56cb4b1c-e0c6-25b2-e063-6394a90ac833	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Sun Pharmaceutical Industries, Inc.	1c18e5fc-bf82-47bc-bfd9-8d3e503569ba	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Sportpharm LLC	313dde2e-fb82-4786-988b-565d3e003c37	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Preferred Pharmaceuticals Inc.	196e24fc-3315-4366-ad40-51b7ea54b211	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	2eff5585-f013-42f0-b678-bb5406e8188c	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	153fed41-6662-4ca9-802f-84b44dcb65e9	2025-09-09	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Sun Pharmaceutical Industries, Inc.	e4e9f244-4a85-4c0d-9917-93182c4a6e87	2025-07-07	Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Direct Rx	bbf26437-c9b4-d8e6-e053-2a95a90a0062	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Advanced Rx Pharmacy of Tennessee, LLC	fe2ec7d2-23c2-e99f-e053-6294a90aa65a	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	4320f2b8-ac47-40f4-9275-e7c5506e30e4	2024-09-11	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Actavis Pharma, Inc.	a6ac4020-2c67-426a-8289-7e54ce43d0c9	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	NORTHSTAR RX LLC	8d03b9ba-f7a8-4fbf-9be1-83d815c2be45	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	NuCare Pharmaceuticals,Inc.	5cc511e4-3e7d-70d6-e053-2a91aa0a8044	2024-06-04	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	5ca32ede-b546-4b65-90d6-c69add760522	2023-09-28	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	b3f69dc2-2b88-4866-baea-aa3b3ed84fb1	2023-05-16	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Proficient Rx LP	3d235926-6f17-4aa5-be82-7f1b4357e247	2022-06-01	Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Proficient Rx LP	c6e4bf5f-f6d6-489e-9286-c30568c601b7	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	Glenmark Pharmaceuticals Inc. USA	8dcd24cb-e568-428a-88ac-737d115cc54d	2020-11-09	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole and Betamethasone Dipropionate

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0370	Clotrimazole and Betamethasone Dipropionate	Clotrimazole and Betamethasone Dipropionate	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current