Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/25/2015 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/07/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English