Details for New Drug Application (NDA): 215401
✉ Email this page to a colleague
NDA 215401 describes XELSTRYM, which is a drug marketed by Noven Pharms Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the XELSTRYM profile page.
The generic ingredient in XELSTRYM is dextroamphetamine. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dextroamphetamine profile page.
The generic ingredient in XELSTRYM is dextroamphetamine. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dextroamphetamine profile page.
Summary for 215401
| Tradename: | XELSTRYM |
| Applicant: | Noven Pharms Inc |
| Ingredient: | dextroamphetamine |
| Patents: | 6 |
Pharmacology for NDA: 215401
| Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 215401
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XELSTRYM | dextroamphetamine | SYSTEM;TRANSDERMAL | 215401 | NDA | Noven Therapeutics, LLC | 68968-0205 | 68968-0205-3 | 30 POUCH in 1 CARTON (68968-0205-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0205-1) |
| XELSTRYM | dextroamphetamine | SYSTEM;TRANSDERMAL | 215401 | NDA | Noven Therapeutics, LLC | 68968-0210 | 68968-0210-3 | 30 POUCH in 1 CARTON (68968-0210-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0210-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;TRANSDERMAL | Strength | 4.5MG/9HR | ||||
| Approval Date: | Mar 22, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 22, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 11,559,501 | Patent Expiration: | Jan 6, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,591,941 | Patent Expiration: | Oct 7, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
