Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022063
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | Yes | No |
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | Yes | No |
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | Yes | No |
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | AB2 | 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 |
|---|---|---|---|---|---|---|---|
| 06/20/2017 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022063s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022063Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/022063Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022063s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021977Orig1s050; 208510Orig1s007; 021303Orig1s038; 022063Orig1s005ltr.pdf | |
| 02/25/2022 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022063s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021303Orig1s036; 021977Orig1s048; 022063Orig1s003; 208510Orig1s005ltr.pdf | |
| 09/13/2019 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022063s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022063Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022063s005lbl.pdf | |
| 10/13/2023 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022063s005lbl.pdf | |
| 02/25/2022 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022063s003lbl.pdf | |
| 02/25/2022 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022063s003lbl.pdf | |
| 09/13/2019 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022063s001lbl.pdf | |
| 06/20/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022063s000lbl.pdf |
MYDAYIS
CAPSULE, EXTENDED RELEASE;ORAL; 3.125MG;3.125MG;3.125MG;3.125MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 211546 | SPECGX LLC |
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215997 | SUN PHARM INDS INC |
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210876 | TEVA PHARMS USA |
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.125MG;3.125MG;3.125MG;3.125MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 022063 | TAKEDA PHARMS USA |
CAPSULE, EXTENDED RELEASE;ORAL; 6.25MG;6.25MG;6.25MG;6.25MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 211546 | SPECGX LLC |
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215997 | SUN PHARM INDS INC |
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210876 | TEVA PHARMS USA |
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 022063 | TAKEDA PHARMS USA |
CAPSULE, EXTENDED RELEASE;ORAL; 9.375MG;9.375MG;9.375MG;9.375MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 211546 | SPECGX LLC |
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215997 | SUN PHARM INDS INC |
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210876 | TEVA PHARMS USA |
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 9.375MG;9.375MG;9.375MG;9.375MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 022063 | TAKEDA PHARMS USA |
CAPSULE, EXTENDED RELEASE;ORAL; 12.5MG;12.5MG;12.5MG;12.5MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 211546 | SPECGX LLC |
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 215997 | SUN PHARM INDS INC |
| DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210876 | TEVA PHARMS USA |
| MYDAYIS | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 12.5MG;12.5MG;12.5MG;12.5MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 022063 | TAKEDA PHARMS USA |