Details for New Drug Application (NDA): 019828
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NDA 019828 describes OXISTAT, which is a drug marketed by Fougera Pharms and Ani Pharms and is included in two NDAs. It is available from two suppliers. Additional details are available on the OXISTAT profile page.
The generic ingredient in OXISTAT is oxiconazole nitrate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the oxiconazole nitrate profile page.
The generic ingredient in OXISTAT is oxiconazole nitrate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the oxiconazole nitrate profile page.
Summary for 019828
| Tradename: | OXISTAT |
| Applicant: | Fougera Pharms |
| Ingredient: | oxiconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 019828
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXISTAT | oxiconazole nitrate | CREAM;TOPICAL | 019828 | NDA AUTHORIZED GENERIC | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0168-0358 | 0168-0358-30 | 30 g in 1 TUBE (0168-0358-30) |
| OXISTAT | oxiconazole nitrate | CREAM;TOPICAL | 019828 | NDA AUTHORIZED GENERIC | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0168-0358 | 0168-0358-60 | 60 g in 1 TUBE (0168-0358-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | EQ 1% BASE | ||||
| Approval Date: | Dec 30, 1988 | TE: | AB | RLD: | Yes | ||||
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