Approvals (Drugs@FDA)

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

BAXTER HLTHCARE CORP · EPINEPHRINE BITARTRATE

NDA218475Drug (NDA)DiscontinuedPrescription
Open FDA's page for this record
Application number
NDA218475
Sponsor name
BAXTER HLTHCARE CORP
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250228
    Review priority
    STANDARD
    Submission class code
    TYPE 5
    Submission class code description
    Type 5 - New Formulation or New Manufacturer
    Application docs
    1. ID
      81393
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218475s000lbl.pdf
      Date
      20250303
      Type
      Label
    2. ID
      81429
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218475Orig1s000ltr.pdf
      Date
      20250304
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    TA
    Submission status date
    20250929
    Review priority
    N/A
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      83642
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218475Orig1s001TAltr.pdf
      Date
      20251003
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      EPINEPHRINE BITARTRATE
      Strength
      EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)
  2. Product number
    002
    Reference drug
    Yes
    Brand name
    EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      EPINEPHRINE BITARTRATE
      Strength
      EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.