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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204326
Company: NEOS THERAPS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADZENYS XR-ODT AMPHETAMINE EQ 3.1MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription AB Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 6.3MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription AB Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 9.4MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription AB Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 12.5MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription AB Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 15.7MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription AB Yes No
ADZENYS XR-ODT AMPHETAMINE EQ 18.8MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription AB Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/27/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204326Orig1_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/23/2025 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204326s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204326Orig1s020ltr.pdf
04/01/2025 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204326Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204326Orig1s018ltr.pdf
03/12/2024 SUPPL-14 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204326Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204326Orig1s014ltr.pdf
03/28/2025 SUPPL-12 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204326Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204326Orig1s012ltr.pdf
10/13/2023 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204326s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204326Orig1s011ltr.pdf
02/25/2022 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204326s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204325Orig1s003; 204326Orig1s008ltr.pdf
01/04/2017 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204326s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204326Orig1s002ltr.pdf
11/18/2016 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
09/23/2025 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204326s020lbl.pdf
09/23/2025 SUPPL-20 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204326s020lbl.pdf
04/01/2025 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204326Orig1s018lbl.pdf
03/28/2025 SUPPL-12 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204326Orig1s012lbl.pdf
03/12/2024 SUPPL-14 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204326Orig1s014lbl.pdf
10/13/2023 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204326s011lbl.pdf
02/25/2022 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204326s008lbl.pdf
01/04/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204326s002lbl.pdf
11/18/2016 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s001lbl.pdf
01/27/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf

ADZENYS XR-ODT

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL; EQ 3.1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADZENYS XR-ODT AMPHETAMINE EQ 3.1MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription Yes AB 204326 NEOS THERAPS
AMPHETAMINE AMPHETAMINE EQ 3.1MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription No AB 209253 ACTAVIS LABS FL INC

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL; EQ 6.3MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADZENYS XR-ODT AMPHETAMINE EQ 6.3MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription Yes AB 204326 NEOS THERAPS
AMPHETAMINE AMPHETAMINE EQ 6.3MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription No AB 209253 ACTAVIS LABS FL INC

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL; EQ 9.4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADZENYS XR-ODT AMPHETAMINE EQ 9.4MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription Yes AB 204326 NEOS THERAPS
AMPHETAMINE AMPHETAMINE EQ 9.4MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription No AB 209253 ACTAVIS LABS FL INC

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL; EQ 12.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADZENYS XR-ODT AMPHETAMINE EQ 12.5MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription Yes AB 204326 NEOS THERAPS
AMPHETAMINE AMPHETAMINE EQ 12.5MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription No AB 209253 ACTAVIS LABS FL INC

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL; EQ 15.7MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADZENYS XR-ODT AMPHETAMINE EQ 15.7MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription Yes AB 204326 NEOS THERAPS
AMPHETAMINE AMPHETAMINE EQ 15.7MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription No AB 209253 ACTAVIS LABS FL INC

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL; EQ 18.8MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADZENYS XR-ODT AMPHETAMINE EQ 18.8MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription Yes AB 204326 NEOS THERAPS
AMPHETAMINE AMPHETAMINE EQ 18.8MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Prescription No AB 209253 ACTAVIS LABS FL INC
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