Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200735
Company: FOUGERA PHARMS INC

Products on ANDA 200735

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 200735

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/14/2014	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200735Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/18/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200735

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	211111	AMNEAL
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	200735	FOUGERA PHARMS INC
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	091282	GLENMARK PHARMS LTD
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	200734	TARO
FLUOCINONIDE	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	No	AB	208989	ZYDUS LIFESCIENCES
VANOS	FLUOCINONIDE	0.1%	CREAM;TOPICAL	Prescription	Yes	AB	021758	BAUSCH