Details for New Drug Application (NDA): 219132
✉ Email this page to a colleague
The generic ingredient in AQNEURSA is levacetylleucine. One supplier is listed for this compound. Additional details are available on the levacetylleucine profile page.
Summary for 219132
Tradename: | AQNEURSA |
Applicant: | Intrabio |
Ingredient: | levacetylleucine |
Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219132
Generic Entry Date for 219132*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
FOR SUSPENSION;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 219132
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AQNEURSA | levacetylleucine | FOR SUSPENSION;ORAL | 219132 | NDA | IntraBio Inc | 83853-101 | 83853-101-01 | 28 PACKET in 1 CARTON (83853-101-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 1GM/PACKET | ||||
Approval Date: | Sep 24, 2024 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Sep 24, 2029 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY |
Complete Access Available with Subscription