Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074905
Company: FOUGERA PHARMS

Products on ANDA 074905

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074905

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/1997	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74905ap.pdf

Therapeutic Equivalents for ANDA 074905

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	TARO
FLUOCINONIDE	FLUOCINONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	073481	TEVA
FLUOCINONIDE	FLUOCINONIDE	0.05%	OINTMENT;TOPICAL	Prescription	No	AB	212976	XIROMED
LIDEX	FLUOCINONIDE	0.05%	OINTMENT;TOPICAL	Prescription	Yes	AB	016909	ALVOGEN