Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214134
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | TABLET, CHEWABLE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/25/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/05/2024 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
LISDEXAMFETAMINE DIMESYLATE
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 | 219258 | GRANULES |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218306 | MSN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218850 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 214134 | SUN PHARM INDS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 215415 | TEVA PHARMS |
| 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 | 219258 | GRANULES |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218306 | MSN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218850 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 214134 | SUN PHARM INDS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 215415 | TEVA PHARMS |
| 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 | 219258 | GRANULES |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218306 | MSN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218850 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 214134 | SUN PHARM INDS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 215415 | TEVA PHARMS |
| 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 | 219258 | GRANULES |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218306 | MSN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218850 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 214134 | SUN PHARM INDS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 215415 | TEVA PHARMS |
| 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 | 219258 | GRANULES |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218306 | MSN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218850 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 214134 | SUN PHARM INDS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 215415 | TEVA PHARMS |
| 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 | 219258 | GRANULES |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218306 | MSN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 218850 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 214134 | SUN PHARM INDS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | TABLET, CHEWABLE;ORAL | Prescription | No | AB | 215415 | TEVA PHARMS |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 60MG | TABLET, CHEWABLE;ORAL | Prescription | Yes | AB | 208510 | TAKEDA PHARMS USA |