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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022312
Company: APOTEX INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOCETAXEL DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE;INJECTION Discontinued None No No
DOCETAXEL DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE;INJECTION 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
01/11/2012 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022312s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022312s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022312_docetaxel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022312Orig1s000SumR.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/11/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022312s000lbl.pdf
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