Approvals (Drugs@FDA)

TOPIRAMATE

MICRO LABS · TOPIRAMATE

ANDA219183Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA219183
Sponsor name
MICRO LABS
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260904
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    004
    Reference drug
    No
    Brand name
    TOPIRAMATE
    Reference standard
    No
    Dosage form
    CAPSULE, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB1
    Active ingredients
    1. Name
      TOPIRAMATE
      Strength
      200MG
  2. Product number
    002
    Reference drug
    No
    Brand name
    TOPIRAMATE
    Reference standard
    No
    Dosage form
    CAPSULE, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB1
    Active ingredients
    1. Name
      TOPIRAMATE
      Strength
      50MG
  3. Product number
    003
    Reference drug
    No
    Brand name
    TOPIRAMATE
    Reference standard
    No
    Dosage form
    CAPSULE, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB1
    Active ingredients
    1. Name
      TOPIRAMATE
      Strength
      100MG
  4. Product number
    001
    Reference drug
    No
    Brand name
    TOPIRAMATE
    Reference standard
    No
    Dosage form
    CAPSULE, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB1
    Active ingredients
    1. Name
      TOPIRAMATE
      Strength
      25MG
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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.