Approvals (Drugs@FDA)

MEXILETINE HYDROCHLORIDE

ZYDUS PHARMS · MEXILETINE HYDROCHLORIDE

ANDA214598Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA214598
Sponsor name
ZYDUS PHARMS
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
    003
    Reference drug
    No
    Brand name
    MEXILETINE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      MEXILETINE HYDROCHLORIDE
      Strength
      250MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    MEXILETINE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      MEXILETINE HYDROCHLORIDE
      Strength
      150MG
  3. Product number
    002
    Reference drug
    No
    Brand name
    MEXILETINE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      MEXILETINE HYDROCHLORIDE
      Strength
      200MG
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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.