Approvals (Drugs@FDA)

KETOROLAC TROMETHAMINE

SHANDONG · KETOROLAC TROMETHAMINE

ANDA218355Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218355
Sponsor name
SHANDONG
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260923
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    KETOROLAC TROMETHAMINE
    Reference standard
    No
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Te code
    AP
    Active ingredients
    1. Name
      KETOROLAC TROMETHAMINE
      Strength
      30MG/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.