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Approvals (Drugs@FDA)

CALREZDY

FRESENIUS MEDCL CARE · CALCUIM CHLORIDE

NDA219456Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA219456
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
      87484
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219456oRIG1s000lbl.pdf
      Date
      20261020
      Type
      Label
    2. ID
      87496
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219456Orig1s000ltr.pdf
      Date
      20261021
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    CALREZDY
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      CALCUIM CHLORIDE
      Strength
      14.7G/L calcium chloride dihydrate (100MMOL/L calcium)
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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.