Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210034
Company: XIROMED

Products on ANDA 210034

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210034

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210034

CLOBETASOL PROPIONATE

CREAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	213291	ALEMBIC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	211256	AMNEAL
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	075338	AUROBINDO PHARMA USA
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	212982	ENCUBE
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	074392	FOUGERA PHARMS INC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	210208	LUPIN
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	211401	RISING
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	074249	SUN PHARMA CANADA
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	211836	TORRENT
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	210034	XIROMED
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	211074	ZYDUS PHARMS