Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208510
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 10MG | TABLET, CHEWABLE;ORAL | Prescription | AB | Yes | No |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 20MG | TABLET, CHEWABLE;ORAL | Prescription | AB | Yes | No |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 30MG | TABLET, CHEWABLE;ORAL | Prescription | AB | Yes | No |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 40MG | TABLET, CHEWABLE;ORAL | Prescription | AB | Yes | No |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 50MG | TABLET, CHEWABLE;ORAL | Prescription | AB | Yes | No |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 60MG | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 01/28/2017 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208510Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208510Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021977s050,208510s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021977Orig1s050; 208510Orig1s007; 021303Orig1s038; 022063Orig1s005ltr.pdf | |
| 02/25/2022 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021977s048,208510s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021303Orig1s036; 021977Orig1s048; 022063Orig1s003; 208510Orig1s005ltr.pdf | |
| 11/02/2021 | SUPPL-4 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021977s047,208510s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021977Orig1s047;208510Orig1s004ltr.pdf | |
| 07/29/2021 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021977s046,208510s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021977Orig1s046; 208510Orig1s003ltr.pdf | |
| 07/31/2017 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s034,208510s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021977Orig1s034,208510Orig1s002ltr.pdf | |
| 05/19/2017 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s045,208510s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021977Origs045,208510Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/13/2023 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021977s050,208510s007lbl.pdf | |
| 02/25/2022 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021977s048,208510s005lbl.pdf | |
| 11/02/2021 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021977s047,208510s004lbl.pdf | |
| 07/29/2021 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021977s046,208510s003lbl.pdf | |
| 07/31/2017 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s034,208510s002lbl.pdf | |
| 05/19/2017 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021977s045,208510s001lbl.pdf | |
| 01/28/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208510lbl.pdf |
VYVANSE
TABLET, CHEWABLE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 217068 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218306 | MSN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 214134 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 10MG | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 208510 | TAKEDA PHARMS USA |
TABLET, CHEWABLE;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 217068 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218306 | MSN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 214134 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 20MG | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 208510 | TAKEDA PHARMS USA |
TABLET, CHEWABLE;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 217068 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218306 | MSN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 214134 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 30MG | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 208510 | TAKEDA PHARMS USA |
TABLET, CHEWABLE;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 217068 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218306 | MSN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 214134 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 40MG | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 208510 | TAKEDA PHARMS USA |
TABLET, CHEWABLE;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 217068 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218306 | MSN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 214134 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 50MG | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 208510 | TAKEDA PHARMS USA |
TABLET, CHEWABLE;ORAL; 60MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 217068 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218306 | MSN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 214134 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 60MG | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 208510 | TAKEDA PHARMS USA |