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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021143
Company: TARO

Products on NDA 021143

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIVAGIZOLE 3	CLOTRIMAZOLE	2%	CREAM;VAGINAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021143

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21143lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21143ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21143_Trivagizole3.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/25/2016	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021143Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021143Orig1s012ltr.pdf
05/15/2014	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/10/2002	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/08/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
09/17/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
01/10/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
10/18/2000	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 021143

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/25/2016	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021143Orig1s012lbl.pdf
04/12/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21143lbl.pdf

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

TRIVAGIZOLE 3

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

CREAM;VAGINAL; 2%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
TRIVAGIZOLE 3	CLOTRIMAZOLE	2%	CREAM;VAGINAL	Over-the-counter	No	021143	TARO

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