Details for New Drug Application (NDA): 076773
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The generic ingredient in MICONAZOLE 3 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 076773
Tradename: | MICONAZOLE 3 |
Applicant: | Taro |
Ingredient: | miconazole nitrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076773
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MICONAZOLE 3 | miconazole nitrate | CREAM;VAGINAL | 076773 | ANDA | TARGET Corporation | 11673-391 | 11673-391-06 | 1 TUBE, WITH APPLICATOR in 1 CARTON (11673-391-06) / 25 g in 1 TUBE, WITH APPLICATOR |
MICONAZOLE 3 | miconazole nitrate | CREAM;VAGINAL | 076773 | ANDA | Topco Associates LLC | 36800-070 | 36800-070-09 | 1 TUBE, WITH APPLICATOR in 1 CARTON (36800-070-09) / 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 2, 2005 | TE: | RLD: | No |
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