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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214121
Company: ACCORD HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHOTREXATE METHOTREXATE 5GM/50ML (100MG/ML) SOLUTION;INTRAVENOUS Discontinued None Yes 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
08/24/2020 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)
Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214121Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214121Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2024 SUPPL-3 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214121s003lbl.pdf
03/10/2022 SUPPL-1 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214121s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214121Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/12/2024 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214121s003lbl.pdf
03/10/2022 SUPPL-1 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214121s001lbl.pdf
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