Home Applications 076294 Application 076294
Type ANDA
Sponsor FOUGERA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 KETOCONAZOLE KETOCONAZOLE CREAM;TOPICAL 2% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A076294-001 KETOCONAZOLE KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076294-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076294-001 KETOCONAZOLE 2% CREAM / TOPICAL AB 2004-04-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ketoconazole KETOCONAZOLE E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC cad7c647-34a9-4e4e-83b3-8d78e58f588f 2026-01-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 076294 application number: ANDA076294 ndc (product): 0168-0099
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0168-0099 ketoconazole ketoconazole E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 0168-0099 ketoconazole ketoconazole E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 0168-0099 ketoconazole ketoconazole E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. ANDA Current 50090-0719 ketoconazole ketoconazole A-S Medication Solutions ANDA Current 50090-0720 ketoconazole ketoconazole A-S Medication Solutions ANDA Current 50090-0720 ketoconazole ketoconazole A-S Medication Solutions ANDA Current 50436-4448 ketoconazole ketoconazole Unit Dose Services ANDA Current 61919-841 KETOCONAZOLE KETOCONAZOLE DIRECT RX ANDA Current 61919-841 KETOCONAZOLE KETOCONAZOLE DIRECT RX ANDA Current 70518-1637 ketoconazole ketoconazole REMEDYREPACK INC. ANDA Current 70518-1637 ketoconazole ketoconazole REMEDYREPACK INC. ANDA Current