Home Applications 019215 Application 019215
Type NDA
Sponsor ROCHE PALO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FEMSTAT BUTOCONAZOLE NITRATE CREAM;VAGINAL 2% 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 N019215-001 FEMSTAT BUTOCONAZOLE NITRATE 2% CREAM / VAGINAL 1985-11-25
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 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019215-001 FEMSTAT 2% CREAM / VAGINAL 1985-11-25 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 · 1 matching rows.