Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088167
Company: FOUGERA PHARMS INC

Products on ANDA 088167

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088167

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/1982	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
04/11/2005	SUPPL-6	Labeling		Label is not available on this site.
06/24/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/09/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 088167

FLUOCINOLONE ACETONIDE

SOLUTION;TOPICAL; 0.01%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION;TOPICAL	Prescription	No	AT	209596	CHARTWELL RX
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION;TOPICAL	Prescription	No	AT	209913	ENCUBE ETHICALS
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION;TOPICAL	Prescription	No	AT	088167	FOUGERA PHARMS INC
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION;TOPICAL	Prescription	No	AT	206422	LUPIN
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION;TOPICAL	Prescription	No	AT	089124	SUN PHARMA CANADA
SYNALAR	FLUOCINOLONE ACETONIDE	0.01%	SOLUTION;TOPICAL	Prescription	Yes	AT	015296	EUROFARMA