Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 210661
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEMETREXED PEMETREXED 100MG INJECTABLE;INJECTION None (Tentative Approval) None No No
PEMETREXED PEMETREXED 500MG INJECTABLE;INJECTION None (Tentative Approval) 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
03/28/2018 ORIG-1 Tentative Approval Type 2 - New Active Ingredient STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210661Orig1s000TAltr.pdf

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