Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090727
Company: EPIC PHARMA LLC

Products on ANDA 090727

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESOXIMETASONE	DESOXIMETASONE	0.05%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090727

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/10/2011	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 090727

DESOXIMETASONE

GEL;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DESOXIMETASONE	DESOXIMETASONE	0.05%	GEL;TOPICAL	Prescription	No	AB	090727	EPIC PHARMA LLC
DESOXIMETASONE	DESOXIMETASONE	0.05%	GEL;TOPICAL	Prescription	No	AB	077552	PADAGIS US
DESOXIMETASONE	DESOXIMETASONE	0.05%	GEL;TOPICAL	Prescription	No	AB	204675	RISING
TOPICORT	DESOXIMETASONE	0.05%	GEL;TOPICAL	Prescription	No	AB	074904	TARO