Details for New Drug Application (NDA): 214755
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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-nine patents protecting this drug. Additional details are available on the LUMRYZ profile page.
The generic ingredient in LUMRYZ is sodium oxybate. There is one drug master file entry for this compound. Six 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 is one drug master file entry for this compound. Six 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: | 29 |
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 | Alkermes, Inc. | 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 | Alkermes, Inc. | 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 | ||||||||
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