Approvals (Drugs@FDA)

PALIPERIDONE

DR REDDYS · PALIPERIDONE

ANDA205559Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA205559
Sponsor name
DR REDDYS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250219
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    PALIPERIDONE
    Reference standard
    No
    Dosage form
    TABLET, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      PALIPERIDONE
      Strength
      9MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    PALIPERIDONE
    Reference standard
    No
    Dosage form
    TABLET, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      PALIPERIDONE
      Strength
      3MG
  3. Product number
    002
    Reference drug
    No
    Brand name
    PALIPERIDONE
    Reference standard
    No
    Dosage form
    TABLET, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      PALIPERIDONE
      Strength
      6MG
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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.