Details for New Drug Application (NDA): 091366
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NDA 091366 describes MICONAZOLE NITRATE, which is a drug marketed by Perrigo R And D, Cosette, Perrigo, Taro, Teva, Teva Pharms, Actavis Pharma, and L Perrigo Co, and is included in twelve NDAs. It is available from twenty-eight suppliers. Additional details are available on the MICONAZOLE NITRATE profile page.
The generic ingredient in MICONAZOLE NITRATE is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
The generic ingredient in MICONAZOLE NITRATE is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
Summary for 091366
| Tradename: | MICONAZOLE NITRATE |
| Applicant: | Perrigo R And D |
| Ingredient: | miconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091366
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MICONAZOLE NITRATE | miconazole nitrate | CREAM;VAGINAL | 091366 | ANDA | Topco Associates LLC | 36800-782 | 36800-782-14 | 3 APPLICATOR in 1 CARTON (36800-782-14) / 5 g in 1 APPLICATOR |
| MICONAZOLE NITRATE | miconazole nitrate | CREAM;VAGINAL | 091366 | ANDA | H E B | 37808-928 | 37808-928-14 | 1 TUBE in 1 CARTON (37808-928-14) / 5 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;VAGINAL | Strength | 4% | ||||
| Approval Date: | Jan 15, 2010 | TE: | RLD: | No | |||||
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