Details for New Drug Application (NDA): 073507
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NDA 073507 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-one 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-one suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
Summary for 073507
| Tradename: | MICONAZOLE NITRATE |
| Applicant: | Cosette |
| Ingredient: | miconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 073507
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MICONAZOLE NITRATE | miconazole nitrate | SUPPOSITORY;VAGINAL | 073507 | ANDA | Strategic Sourcing Services LLC | 49348-833 | 49348-833-61 | 7 SUPPOSITORY in 1 APPLICATOR (49348-833-61) |
| MICONAZOLE NITRATE | miconazole nitrate | SUPPOSITORY;VAGINAL | 073507 | ANDA | H2-Pharma, LLC | 61269-736 | 61269-736-07 | 7 SUPPOSITORY in 1 BOX (61269-736-07) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SUPPOSITORY;VAGINAL | Strength | 100MG | ||||
| Approval Date: | Nov 19, 1993 | TE: | RLD: | No | |||||
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