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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 208510


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NDA 208510 describes VYVANSE, which is a drug marketed by Takeda Pharms Usa and is included in two NDAs. It is available from one supplier. Additional details are available on the VYVANSE profile page.

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. Fifteen suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
Summary for 208510
Tradename:VYVANSE
Applicant:Takeda Pharms Usa
Ingredient:lisdexamfetamine dimesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208510
Medical Subject Heading (MeSH) Categories for 208510
Suppliers and Packaging for NDA: 208510
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510 NDA Takeda Pharmaceuticals America, Inc. 59417-115 59417-115-01 100 TABLET, CHEWABLE in 1 BOTTLE (59417-115-01)
VYVANSE lisdexamfetamine dimesylate TABLET, CHEWABLE;ORAL 208510 NDA Takeda Pharmaceuticals America, Inc. 59417-116 59417-116-01 100 TABLET, CHEWABLE in 1 BOTTLE (59417-116-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength10MG
Approval Date:Jan 28, 2017TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength20MG
Approval Date:Jan 28, 2017TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength30MG
Approval Date:Jan 28, 2017TE:ABRLD:Yes

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