Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074395
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICONAZOLE NITRATE MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/20/1997 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/074395.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/27/2002 SUPPL-3 Labeling

Label is not available on this site.

12/30/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/20/1998 SUPPL-1 Manufacturing (CMC)

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.

SUPPOSITORY;VAGINAL; 100MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
MICONAZOLE NITRATE MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter No 074414 COSETTE
MICONAZOLE NITRATE MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter No 073507 P AND L
MICONAZOLE NITRATE MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter No 074395 PERRIGO
MONISTAT 7 MICONAZOLE NITRATE 100MG SUPPOSITORY;VAGINAL Over-the-counter Yes 018520 MEDTECH PRODUCTS

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