Details for New Drug Application (NDA): 214755
✉ Email this page to a colleague
NDA 214755 describes LUMRYZ, which is a drug marketed by Avadel Cns and is included in one NDA. It is available from one supplier. There are twenty-six patents protecting this drug. Additional details are available on the LUMRYZ profile page.
The generic ingredient in LUMRYZ is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.
The generic ingredient in LUMRYZ is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.
Summary for 214755
| Tradename: | LUMRYZ |
| Applicant: | Avadel Cns |
| Ingredient: | sodium oxybate |
| Patents: | 26 |
Suppliers and Packaging for NDA: 214755
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755 | NDA | Avadel CNS Pharmaceuticals, LLC | 13551-001 | 13551-001-07 | 7 PACKET in 1 CARTON (13551-001-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
| LUMRYZ | sodium oxybate | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 214755 | NDA | Avadel CNS Pharmaceuticals, LLC | 13551-001 | 13551-001-30 | 30 PACKET in 1 CARTON (13551-001-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;ORAL | Strength | 4.5GM/PACKET | ||||
| Approval Date: | May 1, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 1, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | May 1, 2030 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 16, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY | ||||||||
Complete Access Available with Subscription
