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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213286
Company: AUROBINDO PHARMA LTD

Products on ANDA 213286

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213286

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2020	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
08/18/2023	SUPPL-5	Labeling, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/20/2021	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 213286

FLUOXETINE HYDROCHLORIDE

TABLET;ORAL; EQ 10MG 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 10MG BASE	TABLET;ORAL	Prescription	No	AB	208698	ALEMBIC
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	213286	AUROBINDO PHARMA LTD
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	076006	DR REDDYS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	211653	LUPIN LTD
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	203836	PAR FORM
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	210935	SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	212684	STRIDES PHARMA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	211696	UPSHER SMITH LABS

TABLET;ORAL; EQ 20MG 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 20MG BASE	TABLET;ORAL	Prescription	No	AB	208698	ALEMBIC
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	213286	AUROBINDO PHARMA LTD
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	076006	DR REDDYS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	211653	LUPIN LTD
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	203836	PAR FORM
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	210935	SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	212684	STRIDES PHARMA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Prescription	No	AB	211696	UPSHER SMITH LABS

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