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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214657
Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 100MG BASE/4ML (EQ 25MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 500MG BASE/20ML (EQ 25MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/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
05/26/2022 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214657s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214657Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214657Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/21/2023 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214657s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214657Orig1s003ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/21/2023 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214657s003lbl.pdf
05/26/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214657s000lbl.pdf
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