Application 078338

Type: ANDA
Sponsor: FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOTRIMAZOLE	CLOTRIMAZOLE	CREAM;TOPICAL	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
A078338-001	CLOTRIMAZOLE	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB		2008-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078338-001	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	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078338-001	CLOTRIMAZOLE	1%	CREAM / TOPICAL	AB	2008-09-02	`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	A078338-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078338-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078338-001	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 9 · 174 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	YYBA CORP	53472e4c-868f-18f5-e063-6394a90abce7	2026-09-01	Warnings	Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	InvaDerm Corporation	5a5cfed9-0587-7bef-e063-6294a90a64bf	2026-08-31	Warnings	Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE
Clotrimazole 1% Athletes Foot	CLOTRIMAZOLE	Shield Line LLC	9ddb13cd-34ed-2d63-e053-2a95a90ad9da	2026-08-18	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	YYBA CORP	58f1707a-579b-1e06-e063-6294a90a5a9f	2026-08-13	Warnings	Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Shaanxi Shuvita Biotech Co., Ltd	572a5f3d-fb46-5dfa-e063-6294a90a722b	2026-07-21	Warnings	Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE
Tea Tree Antifungal	CLOTRIMAZOLE	HONG KONG UNORDERED TRADING CO., LIMITED	56de35b7-b57d-1c62-e063-6294a90a757d	2026-07-18	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	c64e2290-593f-48a2-a15d-41689f836fda	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE
terrasil Antifungal Cleansing Bar	CLOTRIMAZOLE	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	10a4fde0-87e1-4474-bcb5-255b0a7f1ecb	2026-07-14	Warnings	Name fallback generic name: CLOTRIMAZOLE
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	561d3e64-ab9c-1074-e063-6394a90a1298	2026-07-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Tinea Versicolor Treatment Cream	CLOTRIMAZOLE	Beautivity LLC	32d71d7e-3c78-6b63-e063-6294a90adaed	2026-06-29	Warnings	Name fallback generic name: CLOTRIMAZOLE
Tinea Versicolor Treatment Bar	CLOTRIMAZOLE	Beautivity LLC	33612382-2f12-e9f6-e063-6394a90aaee4	2026-06-29	Warnings	Name fallback generic name: CLOTRIMAZOLE
Tinea Versicolor Treatment Kit	CLOTRIMAZOLE	Beautivity LLC	3361d9a2-daf6-7749-e063-6294a90a3653	2026-06-29	Warnings	Name fallback generic name: CLOTRIMAZOLE
Terramed Just Think Comfort Clotrimazole Antifungal Topical Solution	CLOTRIMAZOLE	Rida LLC	83a9c5dc-c969-43a7-a763-44783710d5d0	2026-06-18	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	YYBA CORP	53fed66b-a371-38d2-e063-6294a90a510e	2026-06-11	Warnings	Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Redpharm Drug	53cafc9f-7761-83a9-e063-6294a90a3437	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Walgreens	7ca79361-6608-4eda-ba5b-16c28eb6c019	2026-06-09	Warnings	Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	13a14d3c-bfce-42b5-8463-4ec69e94774e	2026-06-03	Warnings	Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE
Athletes Foot Cream	CLOTRIMAZOLE	Shenzhen Miandou Technology Co.,Ltd.	53451e74-719e-9499-e063-6394a90a9e5a	2026-06-02	Warnings	Name fallback generic name: CLOTRIMAZOLE
Medi-First Clotrimazole 1% ANTIFUNGAL Cream	CLOTRIMAZOLE	Unifirst First Aid Corporation	522eeb91-8378-32f4-e063-6394a90aff43	2026-05-20	Warnings	Name fallback generic name: CLOTRIMAZOLE
Fungicure Intensive	CLOTRIMAZOLE	Kobayashi Healthcare International, Inc.	1f1b413f-278e-434f-8590-4cf731663f5c	2026-05-15	Warnings	Name fallback generic name: CLOTRIMAZOLE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0133	Clotrimazole	clotrimazole	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0133	Clotrimazole	clotrimazole	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0133	Clotrimazole	clotrimazole	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current