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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079021
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATOMOXETINE HYDROCHLORIDE ATOMOXETINE HYDROCHLORIDE 10MG CAPSULE;ORAL Discontinued None No No
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
02/18/2021 ORIG-1 Approval

Label is not available on this site.

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