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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 020508

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LAC-HYDRIN	AMMONIUM LACTATE	EQ 12% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020508

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/1996	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2004	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20508s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20508s006ltr.pdf
08/25/2000	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20508S5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20508S5ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20508S005_Lac-Hydrin.cfm
07/19/1999	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/13/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/21/1998	SUPPL-2	Manufacturing (CMC)-Formulation		Label is not available on this site.

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

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