Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203378
Company: RISING

Products on ANDA 203378

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 203378

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/2016/203378Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2025	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
05/31/2022	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 203378

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