Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021806
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANDAZOLE METRONIDAZOLE 0.75% GEL;VAGINAL Prescription BX 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
05/20/2005 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021806lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021806ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021806s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/29/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/03/2011 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021806s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021806s003ltr.pdf
09/07/2006 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/03/2011 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021806s003lbl.pdf
05/20/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021806lbl.pdf

VANDAZOLE

There are no Therapeutic Equivalents.

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