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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203640
Company: APOTEX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NILOTINIB HYDROCHLORIDE NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE;ORAL Discontinued None No No
NILOTINIB HYDROCHLORIDE NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE;ORAL Discontinued None No No
NILOTINIB HYDROCHLORIDE NILOTINIB HYDROCHLORIDE EQ 200MG 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
01/05/2024 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203640Orig1s000ltr.pdf
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