Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019931
Company: BAUSCH

Products on NDA 19931

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KLARON	SULFACETAMIDE SODIUM	10%	LOTION;TOPICAL	Prescription	AB	Yes	Yes

Labels for NDA 019931

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/02/2010	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019931s019lbl.pdf
02/21/2003	SUPPL-8	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19931slr008_Aventis_lbl.pdf