Details for New Drug Application (NDA): 021308
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The generic ingredient in MONISTAT 1 COMBINATION PACK is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
Summary for 021308
Tradename: | MONISTAT 1 COMBINATION PACK |
Applicant: | Medtech Products |
Ingredient: | miconazole nitrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021308
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MONISTAT 1 COMBINATION PACK | miconazole nitrate | CREAM, INSERT;TOPICAL, VAGINAL | 021308 | NDA | Insight Pharmaceuticals LLC | 63736-013 | 63736-013-30 | 1 KIT in 1 PACKAGE, COMBINATION (63736-013-30) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM, INSERT;TOPICAL, VAGINAL | Strength | 2%,1.2GM | ||||
Approval Date: | Jun 29, 2001 | TE: | RLD: | Yes |
Expired US Patents for NDA 021308
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Medtech Products | MONISTAT 1 COMBINATION PACK | miconazole nitrate | CREAM, INSERT;TOPICAL, VAGINAL | 021308-001 | Jun 29, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Medtech Products | MONISTAT 1 COMBINATION PACK | miconazole nitrate | CREAM, INSERT;TOPICAL, VAGINAL | 021308-001 | Jun 29, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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