Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078668
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% LOTION;TOPICAL Prescription AB 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
05/20/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2012 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

SULFACETAMIDE SODIUM

LOTION;TOPICAL; 10%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KLARON SULFACETAMIDE SODIUM 10% LOTION;TOPICAL Prescription Yes AB 019931 VALEANT PHARMS NORTH
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% LOTION;TOPICAL Prescription No AB 077015 FOUGERA PHARMS
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% LOTION;TOPICAL Prescription No AB 078649 PERRIGO CO TENNESSEE
SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM 10% LOTION;TOPICAL Prescription No AB 078668 TARO

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