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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207347
Company: NOVEL LABS INC

Products on ANDA 207347

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 207347

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2025	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207347

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

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