Details for New Drug Application (NDA): 074926
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NDA 074926 describes M-ZOLE 3 COMBINATION PACK, which is a drug marketed by Cosette and is included in one NDA. It is available from nine suppliers. Additional details are available on the M-ZOLE 3 COMBINATION PACK profile page.
The generic ingredient in M-ZOLE 3 COMBINATION PACK 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 M-ZOLE 3 COMBINATION PACK 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 074926
| Tradename: | M-ZOLE 3 COMBINATION PACK |
| Applicant: | Cosette |
| Ingredient: | miconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 074926
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| M-ZOLE 3 COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 074926 | ANDA | Walgreens | 0363-9089 | 0363-9089-03 | 1 KIT in 1 PACKAGE, COMBINATION (0363-9089-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE |
| M-ZOLE 3 COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 074926 | ANDA | Major Pharmaceuticals | 0904-5415 | 0904-5415-01 | 1 KIT in 1 PACKAGE, COMBINATION (0904-5415-01) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | Strength | 2%,200MG | ||||
| Approval Date: | Apr 16, 1999 | TE: | RLD: | No | |||||
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