Approvals (Drugs@FDA)

ADZENYS XR-ODT

NEOS THERAPS · AMPHETAMINE

NDA204326Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA204326
Sponsor name
NEOS THERAPS
Submissions
  1. Submission type
    SUPPL
    Submission number
    14
    Submission status
    AP
    Submission status date
    20240312
    Review priority
    N/A
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      78092
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204326Orig1s014ltr.pdf
      Date
      20240409
      Type
      Letter
    2. ID
      78093
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204326Orig1s014lbl.pdf
      Date
      20240409
      Type
      Label
  2. Submission type
    SUPPL
    Submission number
    20
    Submission status
    AP
    Submission status date
    20250923
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      83448
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204326Orig1s020ltr.pdf
      Date
      20250925
      Type
      Letter
    2. ID
      83486
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204326s020lbl.pdf
      Date
      20250925
      Type
      Label
    3. ID
      83487
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204326s020lbl.pdf#page=28
      Date
      20250925
      Type
      Medication Guide
  3. Submission type
    SUPPL
    Submission number
    12
    Submission status
    AP
    Submission status date
    20250328
    Review priority
    N/A
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      82995
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204326Orig1s012ltr.pdf
      Date
      20250731
      Type
      Letter
    2. ID
      83002
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204326Orig1s012lbl.pdf
      Date
      20250731
      Type
      Label
  4. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20161118
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      45923
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s001ltr.pdf
      Date
      20161122
      Type
      Letter
    2. ID
      45987
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s001lbl.pdf
      Date
      20161201
      Type
      Label
  5. Submission type
    SUPPL
    Submission number
    8
    Submission status
    AP
    Submission status date
    20220225
    Review priority
    901 REQUIRED
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      70298
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204325Orig1s003; 204326Orig1s008ltr.pdf
      Date
      20220228
      Type
      Letter
    2. ID
      70386
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204326s008lbl.pdf
      Date
      20220303
      Type
      Label
  6. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20160127
    Review priority
    STANDARD
    Submission class code
    TYPE 5
    Submission class code description
    Type 5 - New Formulation or New Manufacturer
    Application docs
    1. ID
      45921
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s000ltr.pdf
      Date
      20160128
      Type
      Letter
    2. ID
      45922
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf
      Date
      20160128
      Type
      Label
    3. ID
      46434
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204326Orig1_toc.html
      Date
      20161221
      Type
      Review
    4. ID
      51525
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204326 amphetamine clinical prea.pdf
      Date
      19000101
      Type
      Pediatric Medical Review
    5. ID
      51526
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204326 amphetamine clinpharm prea.pdf
      Date
      19000101
      Type
      Pediatric Clinical Pharmacology Review
  7. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20231013
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      75772
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204326Orig1s011ltr.pdf
      Date
      20231016
      Type
      Letter
    2. ID
      75781
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204326s011lbl.pdf
      Date
      20231017
      Type
      Label
  8. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20170104
    Review priority
    901 REQUIRED
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      46685
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204326s002lbl.pdf
      Date
      20170106
      Type
      Label
    2. ID
      46727
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204326Orig1s002ltr.pdf
      Date
      20170109
      Type
      Letter
  9. Submission type
    SUPPL
    Submission number
    18
    Submission status
    AP
    Submission status date
    20250401
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      81808
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204326Orig1s018lbl.pdf
      Date
      20251212
      Type
      Label
    2. ID
      81872
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204326Orig1s018ltr.pdf
      Date
      20250408
      Type
      Letter
Products
  1. Product number
    006
    Reference drug
    Yes
    Brand name
    ADZENYS XR-ODT
    Reference standard
    Yes
    Dosage form
    TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      AMPHETAMINE
      Strength
      EQ 18.8MG BASE
  2. Product number
    004
    Reference drug
    Yes
    Brand name
    ADZENYS XR-ODT
    Reference standard
    No
    Dosage form
    TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      AMPHETAMINE
      Strength
      EQ 12.5MG BASE
  3. Product number
    002
    Reference drug
    Yes
    Brand name
    ADZENYS XR-ODT
    Reference standard
    No
    Dosage form
    TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      AMPHETAMINE
      Strength
      EQ 6.3MG BASE
  4. Product number
    005
    Reference drug
    Yes
    Brand name
    ADZENYS XR-ODT
    Reference standard
    No
    Dosage form
    TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      AMPHETAMINE
      Strength
      EQ 15.7MG BASE
  5. Product number
    003
    Reference drug
    Yes
    Brand name
    ADZENYS XR-ODT
    Reference standard
    No
    Dosage form
    TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      AMPHETAMINE
      Strength
      EQ 9.4MG BASE
  6. Product number
    001
    Reference drug
    Yes
    Brand name
    ADZENYS XR-ODT
    Reference standard
    No
    Dosage form
    TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      AMPHETAMINE
      Strength
      EQ 3.1MG BASE
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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.