Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020508
Company: SUN PHARM INDS INC

Products on NDA 20508

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LAC-HYDRIN	AMMONIUM LACTATE	EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CREAM;TOPICAL	Discontinued	None	Yes	No

Labels for NDA 020508

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2004	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20508s006lbl.pdf
08/25/2000	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20508S5lbl.pdf