Home Applications 205181 Application 205181
Type ANDA
Sponsor TARO PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BUTENAFINE HYDROCHLORIDE BUTENAFINE HYDROCHLORIDE CREAM;TOPICAL 1% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A205181-001 BUTENAFINE HYDROCHLORIDE BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16
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 · 42 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 2026-08-18 06:07:40 2026-07 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205181-001 BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL 2017-11-16 e64feba35796…
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 · 18 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-2100 Athletes Foot Butenafine Hydrochloride Walgreen Company ANDA Current 0363-2101 Jock Itch Butenafine Hydrochloride Walgreen Company ANDA Current 11673-016 Athletes Foot Butenafine Hydrochloride Target Corporation ANDA Current 11822-2100 Athletes Foot Butenafine Hydrochloride Rite Aid Corporation ANDA Current 30142-210 Butenafine Hydrochloride Butenafine Hydrochloride Kroger Company ANDA Current 36800-049 Athletes Foot Butenafine Hydrochloride TOPCO ASSOCIATES LLC ANDA Current 37808-013 Athletes Foot Ultra Butenafine Hydrochloride H E B ANDA Current 49035-178 Butenafine Hydrochloride Butenafine Hydrochloride Wal-Mart Stores Inc ANDA Current 49035-225 Athletes Foot Ultra Butenafine Hydrochloride Wal-Mart Stores Inc ANDA Current 51672-2100 Athletes Foot Butenafine Hydrochloride Taro Pharmaceuticals U.S.A., inc. ANDA Current 51672-2101 Jock Itch Butenafine Hydrochloride Taro Pharmaceuticals U.S.A., inc. ANDA Current 69842-986 Athletes Foot Butenafine Hydrochloride CVS Pharmacy ANDA Current 69842-989 Butenafine Hydrochloride 1% Butenafine Hydrochloride CVS Pharmacy ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 64012 ORIG 2020-07-22 50729 ORIG 2017-12-18