Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076001
Company: TEVA PHARMS USA
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
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 is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/10/2016 SUPPL-40 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/17/2014 SUPPL-39 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/17/2014 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

08/19/2014 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

11/17/2014 SUPPL-36 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/17/2014 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

02/28/2012 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

02/28/2012 SUPPL-32 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/10/2016 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

05/19/2010 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

09/28/2009 SUPPL-25 Labeling

Label is not available on this site.

08/18/2008 SUPPL-22 Labeling

Label is not available on this site.

08/18/2008 SUPPL-20 Labeling

Label is not available on this site.

01/16/2008 SUPPL-17 Labeling

Label is not available on this site.

01/16/2008 SUPPL-15 Labeling

Label is not available on this site.

05/24/2007 SUPPL-14 Labeling

Label is not available on this site.

10/05/2006 SUPPL-13 Labeling

Label is not available on this site.

09/28/2007 SUPPL-9 Labeling

Label is not available on this site.

03/02/2006 SUPPL-5 Labeling

Label is not available on this site.

04/22/2005 SUPPL-4 Labeling

Label is not available on this site.

04/22/2005 SUPPL-3 Labeling

Label is not available on this site.

04/22/2005 SUPPL-2 Labeling

Label is not available on this site.

11/26/2003 SUPPL-1 Labeling

Label is not available on this site.

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

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