Approvals (Drugs@FDA)

METHYLPHENIDATE HYDROCHLORIDE

OXFORD PHARMS · METHYLPHENIDATE HYDROCHLORIDE

ANDA202892Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA202892
Sponsor name
OXFORD PHARMS
Submissions
  1. Submission type
    SUPPL
    Submission number
    13
    Submission status
    AP
    Submission status date
    20260916
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20260916
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20140923
    Submission class code
    UNKNOWN
  4. Submission type
    SUPPL
    Submission number
    9
    Submission status
    AP
    Submission status date
    20260916
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    METHYLPHENIDATE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      METHYLPHENIDATE HYDROCHLORIDE
      Strength
      20MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    METHYLPHENIDATE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      METHYLPHENIDATE HYDROCHLORIDE
      Strength
      5MG
  3. Product number
    002
    Reference drug
    No
    Brand name
    METHYLPHENIDATE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      METHYLPHENIDATE HYDROCHLORIDE
      Strength
      10MG
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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.