Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079209
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;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
03/19/2009 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-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/27/2016 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/11/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

07/11/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/27/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

09/27/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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