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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217569
Company: BAXTER HLTHCARE CORP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VASOPRESSIN IN SODIUM CHLORIDE 0.9% VASOPRESSIN 20UNITS/100ML (0.2UNITS/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
VASOPRESSIN IN SODIUM CHLORIDE 0.9% VASOPRESSIN 40UNITS/100ML (0.4UNITS/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
09/29/2023 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217569s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217569Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217569Orig1s000TOC.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/21/2025 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217569Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217569Orig1s003ltr.pdf
02/05/2024 SUPPL-1 Manufacturing (CMC)-Control Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217569Orig1s001lbl.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/21/2025 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217569Orig1s003lbl.pdf
02/05/2024 SUPPL-1 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217569Orig1s001lbl.pdf
09/29/2023 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217569s000lbl.pdf
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