Details for New Drug Application (NDA): 074760
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NDA 074760 describes MICONAZOLE NITRATE, which is a drug marketed by Perrigo R And D, Cosette, Perrigo, Taro, Teva, Teva Pharms, Actavis Pharma, and L Perrigo Co, and is included in twelve NDAs. It is available from twenty-eight suppliers. Additional details are available on the MICONAZOLE NITRATE profile page.
The generic ingredient in MICONAZOLE NITRATE 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.
The generic ingredient in MICONAZOLE NITRATE 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 074760
| Tradename: | MICONAZOLE NITRATE |
| Applicant: | Perrigo |
| Ingredient: | miconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 074760
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MICONAZOLE NITRATE | miconazole nitrate | CREAM;VAGINAL | 074760 | ANDA | L Perrigo Company | 0113-0214 | 0113-0214-29 | 1 TUBE, WITH APPLICATOR in 1 CARTON (0113-0214-29) / 45 g in 1 TUBE, WITH APPLICATOR |
| MICONAZOLE NITRATE | miconazole nitrate | CREAM;VAGINAL | 074760 | ANDA | L. Perrigo Company | 0113-0825 | 0113-0825-29 | 1 TUBE in 1 CARTON (0113-0825-29) / 45 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM;VAGINAL | Strength | 2% | ||||
| Approval Date: | May 15, 1997 | TE: | RLD: | No | |||||
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