Details for New Drug Application (NDA): 091366
NDA 091366 describes MICONAZOLE NITRATE, which is a drug marketed by Perrigo R And D, Cosette Pharms Nc, Perrigo, Sun Pharma Canada, Teva, Teva Pharms, Actavis Pharma, and L Perrigo Co, and is included in twelve NDAs. It is available from twenty-five suppliers. Additional details are available on the MICONAZOLE NITRATE profile page.
The generic ingredient in MICONAZOLE NITRATE is miconazole nitrate. There is one drug master file entry for this compound. Forty-five 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 is one drug master file entry for this compound. Forty-five 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 | L. Perrigo Company | 0113-7110 | 0113-7110-14 | 3 POUCH in 1 CARTON (0113-7110-14) / 1 APPLICATOR in 1 POUCH / 5 g in 1 APPLICATOR |
| MICONAZOLE NITRATE | miconazole nitrate | CREAM;VAGINAL | 091366 | ANDA | Walgreen Company | 0363-2070 | 0363-2070-14 | 3 APPLICATOR in 1 CARTON (0363-2070-14) / 5 g in 1 APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;VAGINAL | Strength | 4% | ||||
| Approval Date: | Jan 15, 2010 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
