Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202849
Company: PADAGIS ISRAEL

Products on ANDA 202849

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 202849

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/17/2017	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
10/01/2025	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 202849

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