Approvals (Drugs@FDA)

CALCIUM GLUCONATE IN SODIUM CHLORIDE

MILLA PHARMS · CALCIUM GLUCONATE

ANDA219037Generic (ANDA)Prescription
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Application number
ANDA219037
Sponsor name
MILLA PHARMS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260828
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      87082
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219037Orig1s000ltr.pdf
      Date
      20260901
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    CALCIUM GLUCONATE IN SODIUM CHLORIDE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      CALCIUM GLUCONATE
      Strength
      1GM/50ML (20MG/ML)
  2. Product number
    002
    Reference drug
    No
    Brand name
    CALCIUM GLUCONATE IN SODIUM CHLORIDE
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    INTRAVENOUS
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      CALCIUM GLUCONATE
      Strength
      2GM/100ML (20MG/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.