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 6 of 9 · 170 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Terrasil Tinea Treatment MAX CLOTRIMAZOLE Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions d0b14dcb-89a7-42f6-b6ae-8f19c4e6aaaa 2025-07-11 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole 1% Athletes Foot CLOTRIMAZOLE CVS Pharmacy 8731f4ca-84a0-4325-895b-35bf8e2ff0e1 2025-07-08 Warnings Name fallback generic name: CLOTRIMAZOLE CAREONE Clotrimazole CLOTRIMAZOLE American Sales Company 68915156-8927-4ace-9497-5e510d1edcca 2025-07-08 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole Athletes Foot CLOTRIMAZOLE Wal-Mart Stores, Inc. 1440cf4d-e075-4137-a8ee-f41bd449c998 2025-07-08 Warnings Name fallback generic name: CLOTRIMAZOLE Good Neighbor Pharmacy Clotrimazole CLOTRIMAZOLE AmerisourceBergen adf75d72-26a7-4f4e-bba5-34a6fbe2a4cc 2025-07-08 Warnings Name fallback generic name: CLOTRIMAZOLE Kroger ATHLETES FOOT CLOTRIMAZOLE Kroger Company 9e623f18-3e00-4952-b347-337d83fe3acb 2025-07-08 Warnings Name fallback generic name: CLOTRIMAZOLE Kroger Jock Itch CLOTRIMAZOLE Kroger Company cc536b67-8b0b-4939-b0fb-9a9e4188c4e5 2025-07-08 Warnings Name fallback generic name: CLOTRIMAZOLE Rite Aid antifungal ringworm CLOTRIMAZOLE Rite Aid Corporation 1ad7cd82-d01b-403e-a2c1-2302db2a78df 2025-07-08 Warnings Name fallback generic name: CLOTRIMAZOLE Walgreens Clotrimazole 3 CLOTRIMAZOLE Walgreen Company 7fafdebd-b117-4a6b-a499-a4d3ac086ab9 2025-07-08 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole 1% Athletes Foot CLOTRIMAZOLE STRATEGIC SOURCING SERVICES LLC 9aba1345-ef47-4951-8448-a43d6696b616 2025-07-07 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Sun Pharmaceutical Industries, Inc. 3e2041a0-8bef-4be4-b2b1-556446c4a778 2025-07-03 Warnings, Adverse reactions Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Sun Pharmaceutical Industries, Inc. a3a5cbf5-cabb-48d8-8877-74a97f7c0f57 2025-07-03 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Sun Pharmaceutical Industries, Inc. 325a40b0-3e17-47c6-8988-d5396ca5d53f 2025-07-02 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE meijer Athletes Foot CLOTRIMAZOLE Meijer Distribution Inc fdb15cd8-6726-4150-9b9d-6ef3ee01a5d2 2025-07-02 Warnings Name fallback generic name: CLOTRIMAZOLE Rexall Jock Itch CLOTRIMAZOLE Dollar General 11427a79-f262-4702-9b2e-ec1955a9b2da 2025-07-02 Warnings Name fallback generic name: CLOTRIMAZOLE Rexall Athletes Foot CLOTRIMAZOLE Dollar General 664579a1-a5b0-4a4c-bff6-4347f3e1d3bb 2025-07-02 Warnings Name fallback generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Granules Pharmaceuticals Inc. 1280353c-9f96-557e-e063-6294a90a10f9 2025-06-30 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Clotrimazole CLOTRIMAZOLE Sun Pharmaceutical Industries, Inc. f7192955-8f8c-45dd-a215-8ac2c1f6444f 2025-06-12 Warnings Name fallback brand name: Clotrimazole generic name: CLOTRIMAZOLE Terrasil Anti-Fungal Treatment MAX CLOTRIMAZOLE Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions db356cc8-f473-4eb2-b8d8-72606fca9dc0 2025-05-23 Warnings Name fallback generic name: CLOTRIMAZOLE terrasil Folliculitis Cream Maximum Strength CLOTRIMAZOLE Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 35d54756-00dd-bbe1-e063-6394a90a9e02 2025-05-23 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