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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021026
Company: MYLAN

Products on NDA 021026

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VUSION	MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE	0.25%;81.35%;15%	OINTMENT;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021026

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/16/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021026s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021026_vusion_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021026s013lbl.pdf
06/16/2016	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/21/2014	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/01/2010	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021026s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021026s006ltr.pdf
10/03/2007	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021026s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021026s004ltr.pdf

Labels for NDA 021026

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021026s013lbl.pdf
04/01/2010	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021026s006lbl.pdf
10/03/2007	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021026s004lbl.pdf
02/16/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021026s000lbl.pdf

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