Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202827
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | AB | No | No |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | AB | No | No |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | AB | No | No |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | AB | No | No |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | AB | No | No |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | AB | No | No |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;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 |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/17/2024 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
LISDEXAMFETAMINE DIMESYLATE
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 202830 | AMNEAL |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 202830 | AMNEAL |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 202830 | AMNEAL |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 202830 | AMNEAL |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 202830 | AMNEAL |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |
CAPSULE;ORAL; 70MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 202830 | AMNEAL |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 217194 | ALKEM LABS LTD |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 216944 | APOTEX |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 217442 | ASCENT PHARMS INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 202827 | HIKMA |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 215802 | LANNETT CO INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 202835 | MYLAN |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 214547 | NORWICH |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 216266 | PRINSTON INC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 215330 | RHODES PHARMS |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 211840 | SPECGX LLC |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | No | AB | 214484 | SUN PHARM INDS INC |
| VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE;ORAL | Prescription | Yes | AB | 021977 | TAKEDA PHARMS USA |