Details for New Drug Application (NDA): 020670
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NDA 020670 describes MONISTAT 3 COMBINATION PACK, which is a drug marketed by Medtech Products and is included in two NDAs. It is available from two suppliers. Additional details are available on the MONISTAT 3 COMBINATION PACK profile page.
The generic ingredient in MONISTAT 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 MONISTAT 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 020670
| Tradename: | MONISTAT 3 COMBINATION PACK |
| Applicant: | Medtech Products |
| Ingredient: | miconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020670
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MONISTAT 3 COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 020670 | NDA | Insight Pharmaceuticals LLC | 63736-010 | 63736-010-01 | 1 KIT in 1 PACKAGE, COMBINATION (63736-010-01) * 5 g in 1 APPLICATOR * 9 g in 1 TUBE |
| MONISTAT 3 COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 020670 | NDA | Insight Pharmaceuticals LLC | 63736-017 | 63736-017-03 | 1 KIT in 1 PACKAGE, COMBINATION (63736-017-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE |
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | Strength | 2%,200MG | ||||
| Approval Date: | Apr 16, 1996 | TE: | RLD: | Yes | |||||
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