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): 212976
Company: XIROMED

Products on ANDA 212976

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 212976

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212976

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

Top