Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209701
Company: XIROMED

Products on ANDA 209701

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209701

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209701

CLOBETASOL PROPIONATE

OINTMENT;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	211800	ALEMBIC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	075057	AUROBINDO PHARMA USA
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	074089	COSETTE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	211295	ENCUBE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	074407	FOUGERA PHARMS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	215990	MACLEODS PHARMS LTD
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	208841	NOVEL LABS INC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	074248	SUN PHARMA CANADA
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	209701	XIROMED
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	210199	ZYDUS PHARMS