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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210661
Company: AVYXA HOLDINGS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEMETREXED PEMETREXED DIPOTASSIUM EQ 100MG BASE/VIAL POWDER;INTRAVENOUS Prescription None Yes Yes
PEMETREXED PEMETREXED DIPOTASSIUM EQ 500MG BASE/VIAL POWDER;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
06/28/2024 ORIG-2 Approval Type 2 - New Active Ingredient STANDARD Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210661s000lbl.pdf
06/28/2024 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210661Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/28/2024 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210661s000lbl.pdf
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