Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079114
Company: PERRIGO R AND D
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICONAZOLE NITRATE MICONAZOLE NITRATE 2%,1.2GM CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter None No No
MICONAZOLE NITRATE MICONAZOLE NITRATE 2% CREAM; TOPICAL, VAGINAL Over-the-counter None TBD No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/02/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/11/2020 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/25/2017 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

MICONAZOLE NITRATE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CREAM, SUPPOSITORY;TOPICAL, VAGINAL; 2%,1.2GM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MICONAZOLE NITRATE MICONAZOLE NITRATE 2%,1.2GM CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter No 079114 PERRIGO R AND D
MONISTAT 1 COMBINATION PACK MICONAZOLE NITRATE 2%,1.2GM CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter Yes 021308 MEDTECH PRODUCTS

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CREAM; TOPICAL, VAGINAL; 2%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MICONAZOLE NITRATE MICONAZOLE NITRATE 2% CREAM; TOPICAL, VAGINAL Over-the-counter Unknown 079114 PERRIGO R AND D

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