Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206792
Company: NOVEL LABS INC

Products on ANDA 206792

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206792

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/2016	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206792Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 206792

DESOXIMETASONE

OINTMENT;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%	OINTMENT;TOPICAL	Prescription	No	AB	204965	ACTAVIS MID ATLANTIC
DESOXIMETASONE	DESOXIMETASONE	0.25%	OINTMENT;TOPICAL	Prescription	No	AB	201005	EPIC PHARMA LLC
DESOXIMETASONE	DESOXIMETASONE	0.25%	OINTMENT;TOPICAL	Prescription	No	AB	078657	FOUGERA PHARMS
DESOXIMETASONE	DESOXIMETASONE	0.25%	OINTMENT;TOPICAL	Prescription	No	AB	202838	GLENMARK PHARMS LTD
DESOXIMETASONE	DESOXIMETASONE	0.25%	OINTMENT;TOPICAL	Prescription	No	AB	208104	LUPIN
DESOXIMETASONE	DESOXIMETASONE	0.25%	OINTMENT;TOPICAL	Prescription	No	AB	206792	NOVEL LABS INC
DESOXIMETASONE	DESOXIMETASONE	0.25%	OINTMENT;TOPICAL	Prescription	No	AB	077770	PADAGIS ISRAEL
DESOXIMETASONE	DESOXIMETASONE	0.25%	OINTMENT;TOPICAL	Prescription	No	AB	204272	RISING
DESOXIMETASONE	DESOXIMETASONE	0.25%	OINTMENT;TOPICAL	Prescription	No	AB	205206	ZYDUS LIFESCIENCES