Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075514
Company: WOCKHARDT BIO AG

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription AA 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
08/29/2002 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
01/04/2017 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
12/27/2016 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
12/23/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
05/06/2010 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
08/21/2009 SUPPL-9 Labeling

Label is not available on this site.
06/03/2008 SUPPL-8 Labeling

Label is not available on this site.
06/03/2008 SUPPL-7 Labeling

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

Label is not available on this site.
05/09/2007 SUPPL-5 Labeling

Label is not available on this site.
03/02/2006 SUPPL-3 Labeling

Label is not available on this site.
08/31/2005 SUPPL-2 Labeling

Label is not available on this site.

FLUOXETINE HYDROCHLORIDE

SOLUTION;ORAL; EQ 20MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 077849 LANNETT CO INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 076015 PHARM ASSOC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 075920 SPECGX LLC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 075506 TEVA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 075514 WOCKHARDT BIO AG

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