Orange Book product · Brand (NDA)
LEGUBETI
ACETYLCYSTEINE LYSINE
At a glance
Feb 13, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 13, 2024
2 yr 5 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Feb 13, 2027
in 8 mo
Pharmaceutical detail
Active ingredient
ACETYLCYSTEINE LYSINE
Strength
EQ 500MG BASE/PACKET
Dosage form
FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 215040
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Feb 13, 2027
in 8 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
