Details for New Drug Application (NDA): 020827
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NDA 020827 describes MONISTAT 3, which is a drug marketed by Medtech Products and is included in four NDAs. It is available from one supplier. Additional details are available on the MONISTAT 3 profile page.
The generic ingredient in MONISTAT 3 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 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 020827
| Tradename: | MONISTAT 3 |
| Applicant: | Medtech Products |
| Ingredient: | miconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020827
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MONISTAT 3 | miconazole nitrate | CREAM;VAGINAL | 020827 | NDA | Insight Pharmaceuticals LLC | 63736-015 | 63736-015-18 | 3 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-18) / 5 g in 1 TUBE, WITH APPLICATOR |
| MONISTAT 3 | miconazole nitrate | CREAM;VAGINAL | 020827 | NDA | Insight Pharmaceuticals LLC | 63736-015 | 63736-015-25 | 1 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-25) / 25 g in 1 TUBE, WITH APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;VAGINAL | Strength | 4% | ||||
| Approval Date: | Mar 30, 1998 | TE: | RLD: | Yes | |||||
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