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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214134
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 218306 MSN
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 218306 MSN
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 218306 MSN
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 218306 MSN
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 218306 MSN
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 218306 MSN
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
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