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): 203377
Company: RISING

Products on ANDA 203377

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203377

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2016	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203377Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 203377

FLUOCINOLONE ACETONIDE

OIL;TOPICAL; 0.01%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DERMA-SMOOTHE/FS	FLUOCINOLONE ACETONIDE	0.01%	OIL;TOPICAL	Prescription	Yes	AT	019452	HILL DERMAC
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL;TOPICAL	Prescription	No	AT	207345	NOVEL LABS INC
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL;TOPICAL	Prescription	No	AT	207347	NOVEL LABS INC
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL;TOPICAL	Prescription	No	AT	202847	PADAGIS ISRAEL
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL;TOPICAL	Prescription	No	AT	202848	PADAGIS ISRAEL
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL;TOPICAL	Prescription	No	AT	212760	QUAGEN
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL;TOPICAL	Prescription	No	AT	212761	QUAGEN
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL;TOPICAL	Prescription	No	AT	090982	RISING
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL;TOPICAL	Prescription	No	AT	203377	RISING
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL;TOPICAL	Prescription	No	AT	202368	SUN PHARMA CANADA
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL;TOPICAL	Prescription	No	AT	209336	SUN PHARMA CANADA

Top