Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076990
Company: SUN PHARM INDS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
12/13/2004 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
10/23/2015 SUPPL-21 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/05/2014 SUPPL-20 Labeling-Package Insert

Label is not available on this site.
12/05/2014 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
12/05/2014 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/05/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
02/28/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
08/30/2010 SUPPL-13 Labeling

Label is not available on this site.
03/17/2010 SUPPL-12 Labeling

Label is not available on this site.
07/09/2009 SUPPL-11 Labeling

Label is not available on this site.
10/17/2008 SUPPL-9 Labeling

Label is not available on this site.
10/17/2008 SUPPL-8 Labeling

Label is not available on this site.
07/07/2008 SUPPL-7 Labeling

Label is not available on this site.
10/10/2007 SUPPL-6 Labeling

Label is not available on this site.
10/05/2006 SUPPL-5 Labeling

Label is not available on this site.
08/09/2005 SUPPL-2 Labeling

Label is not available on this site.

FLUOXETINE HYDROCHLORIDE

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 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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