Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074799
Company: SUN PHARMA CANADA

Products on ANDA 074799

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074799

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/1996	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/08/2016	SUPPL-12	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/08/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074799

FLUOCINONIDE

SOLUTION;TOPICAL; 0.05%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	209118	CHARTWELL RX
FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	209699	ENCUBE ETHICALS
FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	072934	FOUGERA PHARMS INC
FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	209283	MACLEODS PHARMS LTD
FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	206003	NOVEL LABS INC
FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	216389	QUAGEN
FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	074799	SUN PHARMA CANADA
FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	208948	ZYDUS PHARMS