Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 006530

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AVC	SULFANILAMIDE	15% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CREAM;VAGINAL	Discontinued	None	Yes	No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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 006530

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/1965	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/24/2015	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
01/18/2013	SUPPL-19	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/006530s019lbl.pdf
04/19/2002	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/13/2000	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/24/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/27/1987	SUPPL-8	Labeling		Label is not available on this site.
01/27/1987	SUPPL-7	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/27/1987	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.

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