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 8 of 9 · 170 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clotrimazole 1% CLOTRIMAZOLE Chain Drug Marketing Association Inc. 24ff5ad7-2ff9-b254-e063-6394a90a27a7 2024-10-21 Warnings Name fallback generic name: CLOTRIMAZOLE CAREALL Clotrimazole CLOTRIMAZOLE New World Imports, Inc ebc565bb-e56c-43ba-a5cb-d2fad2aafc4a 2024-10-07 Warnings Name fallback generic name: CLOTRIMAZOLE Micotrin AC CLOTRIMAZOLE PureTek Corporation cbe4dd18-c9ef-a4e4-e053-2995a90a5289 2024-10-01 Warnings Name fallback generic name: CLOTRIMAZOLE Mycozyl AC CLOTRIMAZOLE PureTek Corporation b676d257-3cfd-7f24-e053-2995a90a546e 2024-10-01 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole 1% CLOTRIMAZOLE Dabur India Limited 22916978-303f-e62a-e063-6394a90a2100 2024-09-20 Warnings Name fallback generic name: CLOTRIMAZOLE Major Clotrimazole CLOTRIMAZOLE NuCare Pharmaceuticals,Inc. 562dfc9f-1897-330a-e054-00144ff8d46c 2024-08-14 Warnings Name fallback generic name: CLOTRIMAZOLE clotrimazole CLOTRIMAZOLE NuCare Pharmaceuticals, Inc. 54241254-1d9a-346a-e054-00144ff8d46c 2024-07-17 Warnings Name fallback brand name: clotrimazole generic name: CLOTRIMAZOLE clotrimazole CLOTRIMAZOLE A-S Medication Solutions b63a3fe5-5684-41bc-ad6c-69c54e5b942d 2024-06-20 Warnings Name fallback brand name: clotrimazole generic name: CLOTRIMAZOLE clotrimazole CLOTRIMAZOLE NuCare Pharmaceuticals,Inc. 627375fb-2f20-16bc-e053-2a91aa0a1542 2024-06-06 Warnings Name fallback brand name: clotrimazole generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Cardinal Health 110 dba LEADER 199df107-3384-6e03-e063-6294a90afc38 2024-05-29 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Femmesil CLOTRIMAZOLE Aidance Skincare & Topical Solutions, LLC efddad82-9dc7-4cd9-b33c-7e85f30d992e 2024-05-24 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE QUALITY CHOICE (Chain Drug Marketing Association) 3c676ff0-44a8-40cd-8f85-d39dda3d9637 2024-05-23 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Clotrimazole Antifungal CLOTRIMAZOLE Trifecta Pharmaceuticals USA, LLC. 11bf50db-552e-0a39-e063-6394a90af60d 2024-02-19 Warnings Name fallback generic name: CLOTRIMAZOLE clotrimazole CLOTRIMAZOLE Proficient Rx LP eeb241a3-93ee-4b74-8cbb-65713d15e7e0 2024-01-01 Warnings Name fallback brand name: clotrimazole generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Proficient Rx LP ba1dc4a4-073f-4f30-bb9c-9ed043700431 2024-01-01 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE RUGBY ANTIFUNGAL CLOTRIMAZOLE CLOTRIMAZOLE Proficient Rx LP 7c64553b-589c-4e65-a6f0-b2847bbbe8a6 2024-01-01 Warnings Name fallback generic name: CLOTRIMAZOLE SIMPLY VITAL Antifungal Cream CLOTRIMAZOLE ALPHA PLANTS INC d3842de3-0d13-4dc2-920b-90a4b822bbb8 2023-11-11 Warnings Name fallback generic name: CLOTRIMAZOLE Smooth Gator Fungus Eliminator CLOTRIMAZOLE Smooth Gator, LLC 262b04f5-1b5d-4c67-a557-01f8b1711302 2023-11-10 Warnings Name fallback generic name: CLOTRIMAZOLE Terrasil Jock Itch Treatment Maximum Strength CLOTRIMAZOLE Aidance Skincare & Topical Solutions, LLC c62fbf23-5d19-44ab-9c1a-e9b803192ed0 2023-11-08 Warnings Name fallback generic name: CLOTRIMAZOLE terrasil The Fungal Solution Kit CLOTRIMAZOLE Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 9a5eb581-62a2-41fe-a174-e852fc47e235 2023-11-08 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