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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Argus Health

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074926

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NDA 074926 describes M-ZOLE 3 COMBINATION PACK, which is a drug marketed by Actavis Mid Atlantic and is included in one NDA. It is available from seven suppliers. Additional details are available on the M-ZOLE 3 COMBINATION PACK profile page.

The generic ingredient in M-ZOLE 3 COMBINATION PACK 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 074926
Applicant:Actavis Mid Atlantic
Ingredient:miconazole nitrate
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 074926
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
M-ZOLE 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 074926 ANDA Major Pharmaceuticals 0904-5415 N 0904-5415-01
M-ZOLE 3 COMBINATION PACK miconazole nitrate CREAM, SUPPOSITORY;TOPICAL, VAGINAL 074926 ANDA Rite Aid 11822-7310 N 11822-7310-7

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM, SUPPOSITORY;TOPICAL, VAGINALStrength2%,200MG
Approval Date:Apr 16, 1999TE:RLD:No

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