Approvals (Drugs@FDA)

GLYCEROL PHENYLBUTYRATE

PAI HOLDINGS · GLYCEROL PHENYLBUTYRATE

ANDA220579Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA220579
Sponsor name
PAI HOLDINGS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260728
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    GLYCEROL PHENYLBUTYRATE
    Reference standard
    No
    Dosage form
    LIQUID
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AA
    Active ingredients
    1. Name
      GLYCEROL PHENYLBUTYRATE
      Strength
      1.1GM/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.