Details for New Drug Application (NDA): 020209
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NDA 020209 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 are four drug master file entries 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 are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the oxiconazole nitrate profile page.
Summary for 020209
| Tradename: | OXISTAT |
| Applicant: | Ani Pharms |
| Ingredient: | oxiconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020209
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXISTAT | oxiconazole nitrate | LOTION;TOPICAL | 020209 | NDA | ANI Pharmaceuticals, Inc. | 62559-285 | 62559-285-06 | 6 BOTTLE in 1 CARTON (62559-285-06) / 7 mL in 1 BOTTLE |
| OXISTAT | oxiconazole nitrate | LOTION;TOPICAL | 020209 | NDA | ANI Pharmaceuticals, Inc. | 62559-285 | 62559-285-30 | 1 BOTTLE in 1 CARTON (62559-285-30) / 30 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | EQ 1% BASE | ||||
| Approval Date: | Sep 30, 1992 | TE: | RLD: | Yes | |||||
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