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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209030
Company: PADAGIS US

Products on ANDA 209030

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209030

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209030

FLUOCINONIDE

GEL;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	No	AB	072933	FOUGERA PHARMS INC
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	No	AB	209030	PADAGIS US
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	No	AB	074935	SUN PHARMA CANADA

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