Details for New Drug Application (NDA): 079114
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NDA 079114 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 079114
| Tradename: | MICONAZOLE NITRATE |
| Applicant: | Perrigo R And D |
| Ingredient: | miconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 079114
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MICONAZOLE NITRATE | miconazole nitrate | CREAM, INSERT;TOPICAL, VAGINAL | 079114 | ANDA | Target Corporation | 11673-199 | 11673-199-00 | 1 KIT in 1 CARTON (11673-199-00) * 1 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE |
| MICONAZOLE NITRATE | miconazole nitrate | CREAM, INSERT;TOPICAL, VAGINAL | 079114 | ANDA | Target Corporation | 11673-737 | 11673-737-45 | 1 KIT in 1 CARTON (11673-737-45) * 9 g in 1 TUBE * 1 SWAB in 1 PACKAGE * 1 INSERT in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM, INSERT;TOPICAL, VAGINAL | Strength | 2%,1.2GM | ||||
| Approval Date: | Jun 2, 2010 | TE: | RLD: | No | |||||
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