Details for New Drug Application (NDA): 017450
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NDA 017450 describes MONISTAT 7, which is a drug marketed by Medtech Products and is included in three NDAs. It is available from one supplier. Additional details are available on the MONISTAT 7 profile page.
The generic ingredient in MONISTAT 7 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 7 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 017450
| Tradename: | MONISTAT 7 |
| Applicant: | Medtech Products |
| Ingredient: | miconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 017450
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MONISTAT 7 | miconazole nitrate | CREAM;VAGINAL | 017450 | NDA | Insight Pharmaceuticals LLC | 63736-023 | 63736-023-15 | 1 KIT in 1 PACKAGE, COMBINATION (63736-023-15) * 5 g in 1 TUBE, WITH APPLICATOR * 9 g in 1 TUBE |
| MONISTAT 7 | miconazole nitrate | CREAM;VAGINAL | 017450 | NDA | Insight Pharmaceuticals LLC | 63736-025 | 63736-025-15 | 1 TUBE, WITH APPLICATOR in 1 CARTON (63736-025-15) / 45 g in 1 TUBE, WITH APPLICATOR |
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;VAGINAL | Strength | 2% | ||||
| Approval Date: | Feb 15, 1991 | TE: | RLD: | Yes | |||||
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