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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208419
Company: ACTAVIS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEMETREXED PEMETREXED 100MG/4ML (25MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
PEMETREXED PEMETREXED 500MG/20ML (25MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
PEMETREXED PEMETREXED 1GM/40ML (25MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/21/2020 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208419Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/208419Orig1s000TOC.cfm
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