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 3 of 9 · 170 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clotrimazole CLOTRIMAZOLE Glenmark Pharmaceuticals Inc., USA f6898117-14f3-42d2-bc0e-d296add3ad70 2026-01-30 Warnings, Adverse reactions Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Jock Itch Clotrimazole Antifungal CLOTRIMAZOLE WalMart a7677ad4-5239-40da-809a-501b91caedbf 2026-01-29 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE A-S Medication Solutions bac80746-5cc3-4910-a0af-d43b8242acc6 2026-01-29 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE clotrimazole CLOTRIMAZOLE Padagis Israel Pharmaceuticals Ltd 3dcd0158-ec51-4fa7-a26a-02c2926156c0 2026-01-22 Warnings Name fallback brand name: clotrimazole generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE The Podiatree Company 68a4e3f5-f84d-5650-e053-2a91aa0a171d 2026-01-08 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE The Podiatree Company 79234400-0766-792c-e053-2a91aa0a6e6d 2026-01-08 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Fortinia CLOTRIMAZOLE The Podiatree Company 60ba6f8a-8617-d4f6-e053-2991aa0a4a71 2026-01-08 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole (Topical Solution), 1% CLOTRIMAZOLE Puro Pharma Inc. cb424fa8-3ed5-45cd-b03f-64675584b34e 2025-12-27 Warnings Name fallback generic name: CLOTRIMAZOLE ElixirCurozole CLOTRIMAZOLE ELIXIR HEALTHCARE USA, LLC. 0c468a9e-d092-4704-b742-92ecd9918209 2025-12-26 Warnings Name fallback generic name: CLOTRIMAZOLE CLOTRIMAZOLE CLOTRIMAZOLE GRAXCELL PHARMACEUTICAL, LLC. 5f8ca6ad-cb25-1abf-e053-2a91aa0aca99 2025-12-25 Warnings Name fallback brand name: CLOTRIMAZOLE generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Granules USA, Inc. 6e63e29a-eb50-1790-e053-2a91aa0a3616 2025-12-22 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE RUGBY LABORATORIES 6de9155b-7070-38fd-e053-2a91aa0af6f6 2025-12-19 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Alevazol CLOTRIMAZOLE Capital Pharmaceutical, LLC edd8da89-0b83-4de6-a166-7451d0084169 2025-12-12 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE A-S Medication Solutions 1e7e74f6-9bca-48ab-804a-a7a81df3b608 2025-12-05 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Lotrimin CLOTRIMAZOLE Bayer HealthCare LLC. b584e17f-ed43-43bd-b643-dfa48edd78c6 2025-12-05 Warnings Name fallback generic name: CLOTRIMAZOLE Fungicure Night Cream CLOTRIMAZOLE Kobayashi Healthcare International, Inc. 43029403-2afd-cfa1-e063-6394a90a99a3 2025-12-04 Warnings Name fallback generic name: CLOTRIMAZOLE Lotrimin Antifungal CLOTRIMAZOLE Bayer HealthCare LLC. f9536683-3f32-4c71-9b6a-70f8611e3dcf 2025-12-04 Warnings Name fallback generic name: CLOTRIMAZOLE Lotrimin CLOTRIMAZOLE Bayer HealthCare LLC da948ef3-3709-4bfc-9d17-f6f1ea325343 2025-12-04 Warnings Name fallback generic name: CLOTRIMAZOLE WELMATE Clotrimazole Topical Solution CLOTRIMAZOLE YYBA CORP dc5bac4a-938c-4678-89ac-a899440c6a3c 2025-12-02 Warnings Name fallback generic name: CLOTRIMAZOLE CAREALL Clotrimazole CLOTRIMAZOLE New World Imports, Inc 0a6cb1f7-a2a2-46a2-ae63-d205318996f0 2025-12-01 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