Details for New Drug Application (NDA): 018888
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The generic ingredient in MONISTAT 3 is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
Summary for 018888
Tradename: | MONISTAT 3 |
Applicant: | Medtech Products |
Ingredient: | miconazole nitrate |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;VAGINAL | Strength | 200MG | ||||
Approval Date: | Aug 15, 1984 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 018888
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Medtech Products | MONISTAT 3 | miconazole nitrate | SUPPOSITORY;VAGINAL | 018888-001 | Aug 15, 1984 | 3,717,655 | ⤷ Subscribe |
Medtech Products | MONISTAT 3 | miconazole nitrate | SUPPOSITORY;VAGINAL | 018888-001 | Aug 15, 1984 | 3,839,574 | ⤷ Subscribe |
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