An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071535
Company: COSETTE

Products on ANDA 071535

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071535

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/02/1988	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
02/06/2015	SUPPL-17	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/21/1992	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/21/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/18/1992	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/21/1992	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/21/1992	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/04/1992	SUPPL-2	Labeling		Label is not available on this site.
07/18/1989	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 071535

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	071535	COSETTE
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	209118	GLASSHOUSE PHARMS
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	207554	PAI HOLDINGS PHARM
FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	074799	TARO
FLUOCINONIDE	FLUOCINONIDE	0.05%	SOLUTION;TOPICAL	Prescription	No	AT	208948	ZYDUS PHARMS
LIDEX	FLUOCINONIDE	0.05%	SOLUTION;TOPICAL	Prescription	Yes	AT	018849	ALVOGEN

Top