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Details for New Drug Application (NDA): 021977

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NDA 021977 describes VYVANSE, which is a drug marketed by Shire Development and is included in one NDA. It is available from four suppliers. There are eighteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VYVANSE profile page.

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. There is one drug master file entry for this compound. Four suppliers are listed for this compound. There are thirty tentative approvals for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.

Summary for NDA: 021977

Tradename:
VYVANSE
Applicant:
Shire Development
Ingredient:
lisdexamfetamine dimesylate
Patents:18
Therapeutic Class:Central Nervous System Agents

Pharmacology for NDA: 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 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-751 35356-751-30 30 CAPSULE in 1 BOTTLE (35356-751-30)
VYVANSE
lisdexamfetamine dimesylate
CAPSULE;ORAL 021977 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-751 35356-751-60 60 CAPSULE in 1 BOTTLE (35356-751-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Feb 23, 2007TE:RLD:No
Regulatory Exclusivity Expiration:Oct 14, 2019
Regulatory Exclusivity Use:
Patent:7,223,735Patent Expiration:Feb 24, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:7,655,630Patent Expiration:Feb 24, 2023Product Flag?Substance Flag?YDelist Request?


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