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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021806
Company: TEVA PHARMS

Products on NDA 021806

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VANDAZOLE	METRONIDAZOLE	0.75%	GEL;VAGINAL	Prescription	BX	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021806

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
02/11/2021	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021806s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021806Orig1s008ltr.pdf
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.

Labels for NDA 021806

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021806s008lbl.pdf
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

Therapeutic Equivalents for NDA 021806

VANDAZOLE

There are no Therapeutic Equivalents.

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