Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020676
Company: COMBE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VAGISTAT-1 TIOCONAZOLE 6.5% OINTMENT;VAGINAL Over-the-counter None Yes 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
02/11/1997 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020676_vagistat-1_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/21/2016 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/15/2009 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020676Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020676s009ltr.pdf
12/12/2001 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/09/2001 SUPPL-4 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20676s4lbl.pdf
04/24/2001 SUPPL-3 Labeling

Label is not available on this site.

09/23/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/24/2001 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/15/2009 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020676Orig1s009lbl.pdf
08/09/2001 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20676s4lbl.pdf

VAGISTAT-1

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

OINTMENT;VAGINAL; 6.5%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
TIOCONAZOLE TIOCONAZOLE 6.5% OINTMENT;VAGINAL Over-the-counter No 075915 PERRIGO
VAGISTAT-1 TIOCONAZOLE 6.5% OINTMENT;VAGINAL Over-the-counter Yes 020676 COMBE

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