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Approvals (Drugs@FDA)

CIENBY

FRESENIUS MEDCL CARE · SODIUM CTIRATE

NDA219455Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA219455
Sponsor name
FRESENIUS MEDCL CARE
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20261019
    Review priority
    STANDARD
    Submission class code
    TYPE 2
    Submission class code description
    Type 2 - New Active Ingredient
    Application docs
    1. ID
      87483
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219455Orig1s000lbl.pdf
      Date
      20261020
      Type
      Label
    2. ID
      87495
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219455Orig1s000ltr.pdf
      Date
      20261021
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    CIENBY
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SODIUM CTIRATE
      Strength
      40G/L trisodium citrate dihydrate (136MMOL/L citrate)
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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.