Approvals (Drugs@FDA)

LAMOTRIGINE

LUPIN LTD · LAMOTRIGINE

ANDA078691Generic (ANDA)Discontinued
Open FDA's page for this record
Application number
ANDA078691
Sponsor name
LUPIN LTD
Submissions
  1. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20200121
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20160822
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20110617
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20240531
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  5. Submission type
    SUPPL
    Submission number
    9
    Submission status
    AP
    Submission status date
    20240531
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  6. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    20200121
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  7. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20200121
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  8. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20130412
    Submission class code
    LABELING
    Submission class code description
    Labeling
  9. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20100601
  10. Submission type
    SUPPL
    Submission number
    10
    Submission status
    AP
    Submission status date
    20240531
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  11. Submission type
    SUPPL
    Submission number
    8
    Submission status
    AP
    Submission status date
    20200121
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    003
    Reference drug
    No
    Brand name
    LAMOTRIGINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      LAMOTRIGINE
      Strength
      150MG
  2. Product number
    001
    Reference drug
    No
    Brand name
    LAMOTRIGINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      LAMOTRIGINE
      Strength
      25MG
  3. Product number
    004
    Reference drug
    No
    Brand name
    LAMOTRIGINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      LAMOTRIGINE
      Strength
      200MG
  4. Product number
    002
    Reference drug
    No
    Brand name
    LAMOTRIGINE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Discontinued
    Te code
    AB
    Active ingredients
    1. Name
      LAMOTRIGINE
      Strength
      100MG
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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.