Application 020209
- Type
- NDA
- Sponsor
- FOUGERA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXISTAT | OXICONAZOLE NITRATE | LOTION;TOPICAL | EQ 1% BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020209-001 | OXISTAT | OXICONAZOLE NITRATE | EQ 1% BASE | LOTION / TOPICAL | RLD | 1992-09-30 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N020209-001 | OXISTAT | EQ 1% BASE | LOTION / TOPICAL | RLD, RS | 1992-09-30 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N020209-001 | OXISTAT | EQ 1% BASE | LOTION / TOPICAL | RLD, RS | 1992-09-30 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020209-001 | OXISTAT | EQ 1% BASE | LOTION / TOPICAL | RLD, RS | 1992-09-30 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N020209-001 | OXISTAT | EQ 1% BASE | LOTION / TOPICAL | RLD | 1992-09-30 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Oxiconazole Nitrate | OXICONAZOLE NITRATE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | aa368d2b-a5d2-49dd-86e1-5693b68b46f4 | 2026-01-28 | Warnings, Adverse reactions | OXICONAZOLE NITRATE |
| Oxiconazole Nitrate | OXICONAZOLE NITRATE | Sun Pharmaceutical Industries, Inc. | 04477378-cccc-4db3-9e1b-5c1d6a00bd13 | 2025-07-02 | Warnings, Adverse reactions | OXICONAZOLE NITRATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10337-359 | Oxistat | oxiconazole nitrate | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 10337-359 | Oxistat | oxiconazole nitrate | PharmaDerm a division of Fougera Pharmaceuticals Inc. | NDA | Current |
| 21695-459 | Oxistat | oxiconazole nitrate | Rebel Distributors Corp. | NDA | Current |
| 62559-285 | Oxistat | oxiconazole nitrate | ANI Pharmaceuticals, Inc. | NDA | Current |