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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202827
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 202802 ACTAVIS ELIZABETH
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 202802 ACTAVIS ELIZABETH
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 202802 ACTAVIS ELIZABETH
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 202802 ACTAVIS ELIZABETH
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 202802 ACTAVIS ELIZABETH
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 202802 ACTAVIS ELIZABETH
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 202802 ACTAVIS ELIZABETH
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
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