An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075465
Company: MARKSANS PHARMA

Other Important Information from FDA

Products on ANDA 075465

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 075465

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/2002	ORIG-1	Approval			Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75465_Fluoxetine_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75465_Fluoxetine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75465ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075465_fluoxetine_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2023	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/21/2014	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
04/19/2012	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/22/2011	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/21/2009	SUPPL-16	Labeling		Label is not available on this site.
08/21/2009	SUPPL-15	Labeling		Label is not available on this site.
12/15/2008	SUPPL-14	Labeling		Label is not available on this site.
04/24/2008	SUPPL-13	Labeling		Label is not available on this site.
11/17/2006	SUPPL-12	Labeling		Label is not available on this site.
11/17/2006	SUPPL-11	Labeling		Label is not available on this site.
03/02/2006	SUPPL-10	Labeling		Label is not available on this site.
06/07/2005	SUPPL-8	Labeling		Label is not available on this site.
11/19/2002	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 075465

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/29/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75465_Fluoxetine_Prntlbl.pdf

Therapeutic Equivalents for ANDA 075465

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

Top