Home Applications 078338 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 RLD / RS 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 1 of 2 · 43 observed states.
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 7 of 9 · 170 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clotrimazole CLOTRIMAZOLE Cardinal Health (Leader) 70000 4aaae616-179b-40f1-8a39-6a1ddd414070 2025-04-29 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE ANTIFUNGAL CLOTRIMAZOLE VIVE HEALTH LLC 33db98f5-f6d9-742a-e063-6394a90a2a03 2025-04-28 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole 1% Athletes Foot CLOTRIMAZOLE GERI-GENTLE CORPORATION e673748f-d00b-4ce8-e053-2995a90a9220 2025-04-21 Warnings Name fallback generic name: CLOTRIMAZOLE CLOTRIMAZOLE CLOTRIMAZOLE Rising Pharma Holdings, Inc. 980736aa-751a-4642-ab85-a309435fd02f 2025-03-27 Warnings, Adverse reactions Name fallback brand name: CLOTRIMAZOLE generic name: CLOTRIMAZOLE Forticept Antifungal Foot Gel CLOTRIMAZOLE Lidan, Inc. 1b5851fc-ae73-4e54-bb62-3ff928628b97 2025-03-25 Warnings Name fallback generic name: CLOTRIMAZOLE Dermatin Antifungal CLOTRIMAZOLE Melaleuca, Inc. e993fa3b-1d85-46b7-bda5-ed875be74c4e 2025-03-20 Warnings Name fallback generic name: CLOTRIMAZOLE Forticept Antifungal Foot Cream CLOTRIMAZOLE Lidan, Inc. 17abeb4d-b211-4b8c-a9d2-4c7baba2450c 2025-03-07 Warnings Name fallback generic name: CLOTRIMAZOLE DG Health Athletes Foot CLOTRIMAZOLE Dolgencorp, Inc. 20370b32-21ad-4362-9b46-c6149c907231 2025-02-28 Warnings Name fallback generic name: CLOTRIMAZOLE Family Wellness Clotrimazole 1 Anti Fungal Cream CLOTRIMAZOLE Family Dollar Stores, Inc 0667dd81-5633-494e-857e-45fa276fe72c 2025-02-25 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Preferred Pharmaceuticals Inc. 0052992a-819c-4c55-bd88-201a09a3573a 2025-02-21 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Dr Sheffield Athletes Foot CLOTRIMAZOLE Sheffield Pharmaceuticals LLC b8b8e6b2-1022-4592-91ba-3cf94c7cf318 2025-02-19 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE A-S Medication Solutions 116be3a8-9a57-4b4a-a873-98a4ce83bcf7 2025-02-06 Warnings, Adverse reactions Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Clotrimazole DRS. CLOTRIMAZOLE OL PHARMA TECH,LLC b0e9fc77-6d5c-2472-e053-2995a90a3de4 2025-01-09 Warnings Name fallback brand name: Clotrimazole terrasil Fungal Treatment CLOTRIMAZOLE Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 278290f9-be14-81a8-e063-6294a90ad8cc 2024-12-26 Warnings Name fallback generic name: CLOTRIMAZOLE Rugby Clotrimazole Antifungal Cream CLOTRIMAZOLE Rugby Laboratories a1365bc7-b376-adca-e053-2a95a90acf19 2024-12-20 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole FAMILY WELLNESS CLOTRIMAZOLE Trifecta Pharmaceuticals USA LLC 915759af-0d7b-6a87-e053-2a95a90acbd6 2024-12-13 Warnings Name fallback brand name: Clotrimazole Terrasil JockItch Treatment Maximum Strength CLOTRIMAZOLE Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 8afe11c1-0a85-4255-8eba-e8cbde0759a0 2024-11-20 Warnings Name fallback generic name: CLOTRIMAZOLE Terrasil Ringworm Treatment MAX CLOTRIMAZOLE Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions fc2b740a-49c1-4a01-a94c-8cade52a2b82 2024-11-20 Warnings Name fallback generic name: CLOTRIMAZOLE CLOTRIMAZOLE CLOTRIMAZOLE ALLIED TRADE LINK LLC 266d7b94-2954-4831-e063-6394a90a3f33 2024-11-08 Warnings Name fallback brand name: CLOTRIMAZOLE generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE A-S Medication Solutions 6b908538-d9ff-41d0-909c-01e1d1b21a39 2024-10-23 Warnings Name fallback brand name: Clotrimazole 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