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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090223
Company: ALEMBIC PHARMS LTD

Other Important Information from FDA

Products on ANDA 090223

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 090223

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/2009	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
12/19/2023	SUPPL-31	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/19/2023	SUPPL-29	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/21/2021	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/21/2021	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/12/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/12/2016	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/28/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/28/2012	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/22/2010	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 090223

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	075049	APNAR PHARMA LP
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 PHARMS
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 INC
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
PROZAC	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Prescription	Yes	AB1	018936	ELI LILLY AND CO

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	075049	APNAR PHARMA LP
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 PHARMS
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 INC
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
PROZAC	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	Yes	AB1	018936	ELI LILLY AND CO

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	075049	APNAR PHARMA LP
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 PHARMS
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 INC
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	No	AB	075452	TEVA
PROZAC	FLUOXETINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	018936	ELI LILLY AND CO

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