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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210554
Company: AMNEAL

Products on ANDA 210554

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210554

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/21/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210554

FLUOCINONIDE

CREAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	210554	AMNEAL
FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	073085	COSETTE
FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	073030	FOUGERA PHARMS INC
FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	071500	TARO
FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	072488	TEVA

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