Details for New Drug Application (NDA): 020209
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The generic ingredient in OXISTAT is oxiconazole nitrate. There are four drug master file entries for this compound. Four 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 | PharmaDerm a division of Fougera Pharmaceuticals Inc. | 10337-359 | 10337-359-07 | 7 mL in 1 BOTTLE (10337-359-07) |
OXISTAT | oxiconazole nitrate | LOTION;TOPICAL | 020209 | NDA | PharmaDerm a division of Fougera Pharmaceuticals Inc. | 10337-359 | 10337-359-30 | 1 BOTTLE in 1 CARTON (10337-359-30) / 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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