Drugs@FDA: FDA-Approved Drugs
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 |
---|---|---|---|---|---|
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 | |
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 |
---|---|---|---|---|---|
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 |
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 |
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 |
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 |
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 |
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 |