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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204597
Company: SCIEGEN PHARMS

Products on ANDA 204597

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	AB1	No	No
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	AB1	No	No
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204597

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2015	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
01/09/2024	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/09/2024	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
03/01/2021	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/29/2019	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/29/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/29/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204597

FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB1	090223	ALEMBIC PHARMS LTD
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB1	078619	AUROBINDO PHARMA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB1	206993	CADILA PHARMS LTD
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB1	201336	HERITAGE
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB1	075245	IVAX SUB TEVA PHARMS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB1	075464	LANDELA PHARM
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB1	075465	MARKSANS PHARMA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB1	216232	MICRO LABS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB1	204597	SCIEGEN PHARMS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB1	075049	SENORES PHARMS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB1	075452	TEVA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	No	AB1	076001	TEVA PHARMS USA

CAPSULE;ORAL; EQ 20MG BASE
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB1	090223	ALEMBIC PHARMS LTD
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB1	078619	AUROBINDO PHARMA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB1	206993	CADILA PHARMS LTD
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB1	201336	HERITAGE
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB1	075245	IVAX SUB TEVA PHARMS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB1	075464	LANDELA PHARM
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB1	075465	MARKSANS PHARMA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB1	216232	MICRO LABS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB1	204597	SCIEGEN PHARMS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB1	075049	SENORES PHARMS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB1	075452	TEVA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	No	AB1	076001	TEVA PHARMS USA

CAPSULE;ORAL; EQ 40MG 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 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	090223	ALEMBIC PHARMS LTD
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	078619	AUROBINDO PHARMA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	206993	CADILA PHARMS LTD
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	201336	HERITAGE
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	075245	IVAX SUB TEVA PHARMS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	075465	MARKSANS PHARMA
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	216232	MICRO LABS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	204597	SCIEGEN PHARMS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	075049	SENORES PHARMS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	075452	TEVA

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