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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218475
Company: BAXTER HLTHCARE CORP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EPINEPHRINE BITARTRATE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EPINEPHRINE BITARTRATE EQ 4MG BASE/250ML (EQ 16MCG 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
02/28/2025 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218475s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218475Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2025 SUPPL-1 Manufacturing (CMC)-New Strength Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218475Orig1s001TAltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/28/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218475s000lbl.pdf
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