Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021143
Company: TARO
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
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.

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

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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