Details for New Drug Application (NDA): 021261
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NDA 021261 describes MONISTAT 3 COMBINATION PACK (PREFILLED), which is a drug marketed by Medtech Products and is included in one NDA. Additional details are available on the MONISTAT 3 COMBINATION PACK (PREFILLED) profile page.
The generic ingredient in MONISTAT 3 COMBINATION PACK (PREFILLED) 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 (PREFILLED) 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 021261
| Tradename: | MONISTAT 3 COMBINATION PACK (PREFILLED) |
| Applicant: | Medtech Products |
| Ingredient: | miconazole nitrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;TOPICAL, VAGINAL | Strength | 2%,4% | ||||
| Approval Date: | Feb 2, 2001 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;TOPICAL, VAGINAL | Strength | 2%,4% | ||||
| Approval Date: | Jun 17, 2003 | TE: | RLD: | Yes | |||||
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