Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075245
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Prescription AB1 No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG 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
01/31/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75245ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/10/2016 SUPPL-35 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/10/2016 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

01/10/2016 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

01/10/2016 SUPPL-32 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/10/2016 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

05/13/2010 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

10/26/2009 SUPPL-28 Labeling

Label is not available on this site.

03/30/2009 SUPPL-27 Labeling

Label is not available on this site.

08/21/2008 SUPPL-26 Labeling

Label is not available on this site.

06/15/2009 SUPPL-22 Labeling

Label is not available on this site.

02/11/2008 SUPPL-19 Labeling

Label is not available on this site.

10/24/2007 SUPPL-18 Labeling

Label is not available on this site.

10/24/2007 SUPPL-17 Labeling

Label is not available on this site.

12/14/2005 SUPPL-16 Labeling

Label is not available on this site.

12/14/2005 SUPPL-15 Labeling

Label is not available on this site.

10/19/2004 SUPPL-11 Labeling

Label is not available on this site.

09/28/2004 SUPPL-3 Labeling

Label is not available on this site.

08/16/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

FLUOXETINE HYDROCHLORIDE

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 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 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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