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Last Updated: June 14, 2024

Details for New Drug Application (NDA): 021977


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NDA 021977 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 021977
Tradename:VYVANSE
Applicant:Takeda Pharms Usa
Ingredient:lisdexamfetamine dimesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021977
Medical Subject Heading (MeSH) Categories for 021977
Suppliers and Packaging for NDA: 021977
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977 NDA Takeda Pharmaceuticals America, Inc. 59417-101 59417-101-10 100 CAPSULE in 1 BOTTLE (59417-101-10)
VYVANSE lisdexamfetamine dimesylate CAPSULE;ORAL 021977 NDA Takeda Pharmaceuticals America, Inc. 59417-102 59417-102-10 100 CAPSULE in 1 BOTTLE (59417-102-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Feb 23, 2007TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Feb 23, 2007TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength70MG
Approval Date:Feb 23, 2007TE:ABRLD:Yes

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