Details for New Drug Application (NDA): 076357
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NDA 076357 describes MICONAZOLE 3 COMBINATION PACK, which is a drug marketed by Perrigo and is included in one NDA. It is available from eight suppliers. Additional details are available on the MICONAZOLE 3 COMBINATION PACK profile page.
The generic ingredient in MICONAZOLE 3 COMBINATION PACK 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 MICONAZOLE 3 COMBINATION PACK 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 076357
| Tradename: | MICONAZOLE 3 COMBINATION PACK |
| Applicant: | Perrigo |
| Ingredient: | miconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076357
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MICONAZOLE 3 COMBINATION PACK | miconazole nitrate | CREAM;TOPICAL, VAGINAL | 076357 | ANDA | Rugby Laboratories | 0536-1425 | 0536-1425-41 | 1 KIT in 1 CARTON (0536-1425-41) * 1 APPLICATOR in 1 POUCH (0113-7198-00) / 5 g in 1 APPLICATOR * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBE |
| MICONAZOLE 3 COMBINATION PACK | miconazole nitrate | CREAM;TOPICAL, VAGINAL | 076357 | ANDA | Target Corporation | 11673-982 | 11673-982-00 | 1 KIT in 1 CARTON (11673-982-00) * 1 APPLICATOR in 1 POUCH / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON / 9 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;TOPICAL, VAGINAL | Strength | 2%,4% | ||||
| Approval Date: | Mar 30, 2004 | TE: | RLD: | No | |||||
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