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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209411
Company: BEACH PRODS

Products on ANDA 209411

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOBETASOL PROPIONATE (EMOLLIENT)	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209411

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/21/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209411

CLOBETASOL PROPIONATE (EMOLLIENT)

CREAM;TOPICAL; 0.05%
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOBETASOL PROPIONATE (EMOLLIENT)	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB2	209411	BEACH PRODS
CLOBETASOL PROPIONATE (EMOLLIENT)	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB2	075430	FOUGERA PHARMS
CLOBETASOL PROPIONATE (EMOLLIENT)	CLOBETASOL PROPIONATE	0.05%	CREAM;TOPICAL	Prescription	No	AB2	075633	SUN PHARMA CANADA

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