Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075008
Company: SUN PHARMA CANADA

Products on ANDA 075008

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075008

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75008ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/13/2004	SUPPL-4	Labeling		Label is not available on this site.
03/15/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075008

FLUOCINONIDE

OINTMENT;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%	OINTMENT;TOPICAL	Prescription	No	AB	207538	CHARTWELL RX
FLUOCINONIDE	FLUOCINONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	074905	FOUGERA PHARMS
FLUOCINONIDE	FLUOCINONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	075008	SUN PHARMA CANADA
FLUOCINONIDE	FLUOCINONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	073481	TEVA
FLUOCINONIDE	FLUOCINONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	212976	XIROMED