Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020508
Company: SUN PHARM INDS INC
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LAC-HYDRIN AMMONIUM LACTATE EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CREAM;TOPICAL Discontinued None No No
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.

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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