Details for New Drug Application (NDA): 021977
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The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. One supplier is 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: | 18 |
Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 021977
Generic Entry Date for 021977*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 021977
Physiological Effect | Central Nervous System Stimulation |
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: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
Approval Date: | Feb 23, 2007 | TE: | RLD: | Yes | |||||
Patent: | See Plans and Pricing | Patent Expiration: | Aug 24, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | See Plans and Pricing | Patent Expiration: | Aug 24, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | See Plans and Pricing | Patent Expiration: | Aug 24, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y |
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