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. 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 021977
| Tradename: | VYVANSE |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | lisdexamfetamine dimesylate |
| Patents: | 0 |
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: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Feb 23, 2007 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 70MG | ||||
| Approval Date: | Feb 23, 2007 | TE: | AB | RLD: | Yes | ||||
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