Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078369
Company: FOUGERA PHARMS

Products on ANDA 078369

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078369

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2010	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
06/14/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/13/2014	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078369

DESOXIMETASONE

CREAM;TOPICAL; 0.25%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	205082	ACTAVIS MID ATLANTIC
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	078369	FOUGERA PHARMS
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	208164	LUPIN
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	076510	PADAGIS ISRAEL
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	205594	RISING
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	203234	SCIEGEN PHARMS
DESOXIMETASONE	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	205620	ZYDUS LIFESCIENCES
TOPICORT	DESOXIMETASONE	0.25%	CREAM;TOPICAL	Prescription	No	AB	073193	TARO