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Last Updated: September 26, 2021

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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 Pharms, Teva, Teva Pharms, Actavis Pharma, and P And L, and is included in twelve NDAs. It is available from twenty-seven 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. Forty-seven suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
Summary for 074760
Ingredient:miconazole nitrate
Formulation / Manufacturing:see details
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:OTCDosage:CREAM;VAGINALStrength2%
Approval Date:May 15, 1997TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
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