Approvals (Drugs@FDA)

LISDEXAMFETAMINE DIMESYLATE

MSN · LISDEXAMFETAMINE DIMESYLATE

ANDA218306Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA218306
Sponsor name
MSN
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20240202
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    006
    Reference drug
    No
    Brand name
    LISDEXAMFETAMINE DIMESYLATE
    Reference standard
    No
    Dosage form
    TABLET, CHEWABLE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      LISDEXAMFETAMINE DIMESYLATE
      Strength
      60MG
  2. Product number
    004
    Reference drug
    No
    Brand name
    LISDEXAMFETAMINE DIMESYLATE
    Reference standard
    No
    Dosage form
    TABLET, CHEWABLE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      LISDEXAMFETAMINE DIMESYLATE
      Strength
      40MG
  3. Product number
    002
    Reference drug
    No
    Brand name
    LISDEXAMFETAMINE DIMESYLATE
    Reference standard
    No
    Dosage form
    TABLET, CHEWABLE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      LISDEXAMFETAMINE DIMESYLATE
      Strength
      20MG
  4. Product number
    005
    Reference drug
    No
    Brand name
    LISDEXAMFETAMINE DIMESYLATE
    Reference standard
    No
    Dosage form
    TABLET, CHEWABLE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      LISDEXAMFETAMINE DIMESYLATE
      Strength
      50MG
  5. Product number
    003
    Reference drug
    No
    Brand name
    LISDEXAMFETAMINE DIMESYLATE
    Reference standard
    No
    Dosage form
    TABLET, CHEWABLE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      LISDEXAMFETAMINE DIMESYLATE
      Strength
      30MG
  6. Product number
    001
    Reference drug
    No
    Brand name
    LISDEXAMFETAMINE DIMESYLATE
    Reference standard
    No
    Dosage form
    TABLET, CHEWABLE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      LISDEXAMFETAMINE DIMESYLATE
      Strength
      10MG
Harmonized identifiers (openFDA)
Application number
ANDA218306
Brand name
LISDEXAMFETAMINE DIMESYLATE
Generic name
LISDEXAMFETAMINE DIMESYLATE
Manufacturer name
Novadoz Pharmaceuticals LLC
Product NDC
72205-132, 72205-133, 72205-134, 72205-135, 72205-136, 72205-137
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
LISDEXAMFETAMINE DIMESYLATE
RxCUI
1871456, 1871460, 1871462, 1871464, 1871466, 1871468
SPL ID
a79cb70c-0bfa-4d68-9a21-a5ef4bc3c811
SPL set ID
a79cb70c-0bfa-4d68-9a21-a5ef4bc3c811
Package NDC
72205-132-91, 72205-133-91, 72205-134-91, 72205-135-91, 72205-136-91, 72205-137-91
UNII
SJT761GEGS
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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.