Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079017
Company: ZYDUS PHARMS USA INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 18MG CAPSULE;ORAL Discontinued None No No
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 25MG CAPSULE;ORAL Discontinued None No No
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 40MG CAPSULE;ORAL Discontinued None No No
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 60MG CAPSULE;ORAL Discontinued None No No
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 80MG CAPSULE;ORAL Discontinued None No No
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 100MG 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
09/16/2010 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
08/25/2015 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
08/25/2015 SUPPL-5 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
08/07/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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