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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209419
Company: PH HEALTH

Products on ANDA 209419

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209419

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209419Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/20/2023	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/20/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209419

FLUOXETINE HYDROCHLORIDE

TABLET;ORAL; EQ 60MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET;ORAL	Prescription	No	AB	213265	AUROBINDO PHARMA LTD
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET;ORAL	Prescription	No	AB	211721	DR REDDYS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET;ORAL	Prescription	No	AB	209695	INVENTIA HLTHCARE
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET;ORAL	Prescription	No	AB	209419	PH HEALTH
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET;ORAL	Prescription	No	AB	211282	SCIEGEN PHARMS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET;ORAL	Prescription	No	AB	211477	SOMERSET THERAPS LLC
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 60MG BASE	TABLET;ORAL	Prescription	No	AB	212683	STRIDES PHARMA

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