Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076015
Company: PHARM ASSOC
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/30/2002 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-13 Labeling-Package Insert

Label is not available on this site.

12/27/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/11/2014 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/11/2014 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/31/2012 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/26/2013 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

09/20/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/28/2009 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

01/02/2009 SUPPL-4 Labeling

Label is not available on this site.

01/31/2006 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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