Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 006530
Company: MYLAN SPECIALITY LP

Products on NDA 6530

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVC	SULFANILAMIDE	15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CREAM;VAGINAL	Discontinued	None	Yes	No
AVC	SULFANILAMIDE	1.05GM	SUPPOSITORY;VAGINAL	Discontinued	None	No	No

Labels for NDA 006530

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2013	SUPPL-19	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006530s019lbl.pdf