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. Seventeen suppliers are listed for this compound. Additional details are available on the lisdexamfetamine dimesylate profile page.
The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. Seventeen 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 |
Pharmacology for NDA: 208510
| Physiological Effect | Central Nervous System Stimulation |
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: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 28, 2017 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 20MG | ||||
| Approval Date: | Jan 28, 2017 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 30MG | ||||
| Approval Date: | Jan 28, 2017 | TE: | AB | RLD: | Yes | ||||
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