Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074926
Company: P AND L
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
M-ZOLE 3 COMBINATION PACK MICONAZOLE NITRATE 2%,200MG CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter None No 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
04/16/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-926_Miconazole%20Nitrate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74926ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-926_Miconazole.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/19/2018 SUPPL-18 Labeling-Container/Carton Labels

Label is not available on this site.

04/08/2005 SUPPL-8 Labeling

Label is not available on this site.

08/14/2003 SUPPL-6 Labeling

Label is not available on this site.

11/21/2002 SUPPL-4 Labeling

Label is not available on this site.

03/15/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/16/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-926_Miconazole%20Nitrate_Prntlbl.pdf

M-ZOLE 3 COMBINATION PACK

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%,200MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
M-ZOLE 3 COMBINATION PACK MICONAZOLE NITRATE 2%,200MG CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter No 074926 P AND L
MICONAZOLE NITRATE COMBINATION PACK MICONAZOLE NITRATE 2%,200MG CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter No 075329 PERRIGO
MONISTAT 3 COMBINATION PACK MICONAZOLE NITRATE 2%,200MG CREAM, SUPPOSITORY;TOPICAL, VAGINAL Over-the-counter Yes 020670 MEDTECH PRODUCTS

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