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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208746
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEMETREXED DITROMETHAMINE PEMETREXED DITROMETHAMINE EQ 100MG BASE/VIAL POWDER;INTRAVENOUS Prescription TBD Yes Yes
PEMETREXED DITROMETHAMINE PEMETREXED DITROMETHAMINE EQ 500MG BASE/VIAL POWDER;INTRAVENOUS Prescription TBD Yes Yes
PEMETREXED DITROMETHAMINE PEMETREXED DITROMETHAMINE EQ 1GM BASE/VIAL POWDER;INTRAVENOUS Prescription TBD 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
06/10/2022 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208746s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208746Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/10/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208746s000lbl.pdf

PEMETREXED DITROMETHAMINE

There are no Therapeutic Equivalents.

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