Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212762
Company: QUAGEN

Products on ANDA 212762

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 212762

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212762

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	PATRIN
FLUOCINOLONE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL/DROPS;OTIC	Prescription	No	AT	203378	LYNE
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	213264	TASMAN PHARMA
FLUOCINONIDE ACETONIDE	FLUOCINOLONE ACETONIDE	0.01%	OIL/DROPS;OTIC	Prescription	No	AT	211815	GLENMARK PHARMS LTD