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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208563
Company: TARO

Products on ANDA 208563

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208563

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208563

CLOBETASOL PROPIONATE

AEROSOL, FOAM;TOPICAL; 0.05%
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB2	211450	GLENMARK PHARMS LTD
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB2	201402	PADAGIS ISRAEL
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB2	208563	TARO

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