Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208989
Company: ZYDUS LIFESCIENCES

Products on ANDA 208989

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208989

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/10/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208989

FLUOCINONIDE

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	200735	FOUGERA PHARMS INC
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	200734	SUN PHARMA CANADA
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	208989	ZYDUS LIFESCIENCES
VANOS	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	Yes	AB	021758	BAUSCH