Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200302
Company: SUN PHARMA CANADA

Products on ANDA 200302

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200302

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/2012	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
09/06/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200302

CLOBETASOL PROPIONATE

LOTION;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%	LOTION;TOPICAL	Prescription	No	AB	078223	ACTAVIS MID ATLANTIC
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	LOTION;TOPICAL	Prescription	No	AB	209147	LUPIN
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	LOTION;TOPICAL	Prescription	No	AB	200302	SUN PHARMA CANADA
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	LOTION;TOPICAL	Prescription	No	AB	205249	ZYDUS LIFESCIENCES
CLOBEX	CLOBETASOL PROPIONATE	0.05%	LOTION;TOPICAL	Prescription	Yes	AB	021535	GALDERMA LABS LP