Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076922
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Discontinued None No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Discontinued None No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 40MG BASE CAPSULE;ORAL Discontinued None 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
12/16/2004 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
12/17/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

09/16/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

02/28/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

02/28/2012 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/25/2010 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/25/2010 SUPPL-3 Labeling

Label is not available on this site.

09/25/2008 SUPPL-2 Labeling

Label is not available on this site.

09/15/2005 SUPPL-1 Labeling

Label is not available on this site.

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