Home Applications 019828 Application 019828
Type NDA
Sponsor FOUGERA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OXISTAT OXICONAZOLE NITRATE CREAM;TOPICAL EQ 1% BASE Yes Yes
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 N019828-001 OXISTAT OXICONAZOLE NITRATE EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019828-001 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 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019828-001 OXISTAT EQ 1% BASE CREAM / TOPICAL AB RLD, RS 1988-12-30 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 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0168-0358 Oxiconazole Nitrate Oxiconazole Nitrate E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 0168-0358 Oxiconazole Nitrate Oxiconazole Nitrate E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 10337-358 Oxistat oxiconazole nitrate PharmaDerm a division of Fougera Pharmaceuticals Inc. NDA Current 10337-358 Oxistat oxiconazole nitrate PharmaDerm a division of Fougera Pharmaceuticals Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 33994 SUPPL 2004-02-02 19269 SUPPL 2004-01-29