Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075915
Company: PERRIGO

Products on ANDA 075915

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIOCONAZOLE	TIOCONAZOLE	6.5%	OINTMENT;VAGINAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075915

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2001	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75915.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075915.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2015	SUPPL-25	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/30/2007	SUPPL-15	Labeling		Label is not available on this site.
10/10/2003	SUPPL-6	Labeling		Label is not available on this site.
12/09/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

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

TIOCONAZOLE

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