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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020676
Company: COMBE

Products on NDA 020676

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020676

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.

Labels for NDA 020676

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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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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