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): 213264
Company: TP ANDA HOLDINGS

Products on ANDA 213264

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213264

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213264

FLUOCINOLONE ACETONIDE

OIL/DROPS;OTIC; 0.01%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DERMOTIC	FLUOCINOLONE ACETONIDE	0.01%	OIL/DROPS;OTIC	Prescription	Yes	AT	019452	HILL DERMAC
FLAC	FLUOCINOLONE ACETONIDE	0.01%	OIL/DROPS;OTIC	Prescription	No	AT	210736	ANDA REPOSITORY
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL/DROPS;OTIC	Prescription	No	AT	202849	PADAGIS ISRAEL
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL/DROPS;OTIC	Prescription	No	AT	212762	QUAGEN
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL/DROPS;OTIC	Prescription	No	AT	203378	RISING
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL/DROPS;OTIC	Prescription	No	AT	213264	TP ANDA HOLDINGS

Top