Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078668
Company: TARO

Products on ANDA 078668

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078668

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.

Therapeutic Equivalents for ANDA 078668

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	BAUSCH
SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	LOTION;TOPICAL	Prescription	No	AB	077015	FOUGERA PHARMS
SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	LOTION;TOPICAL	Prescription	No	AB	078649	PADAGIS US
SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	LOTION;TOPICAL	Prescription	No	AB	078668	TARO