Drugs@FDA: FDA Approved Drug Products

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

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

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 074803 BARR
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 INC
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 204597 SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Prescription No AB1 075658 SPECGX LLC
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 074803 BARR
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 INC
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 204597 SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription No AB1 075658 SPECGX LLC
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 INC
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 204597 SCIEGEN PHARMS INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Prescription No AB 076990 SUN PHARM INDS LTD
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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