Orange Book product · Brand (NDA)
NEOPROFEN
IBUPROFEN LYSINE
Brand (NDA)NDA 021903TE APRX RECORDATI RARE
At a glance
Apr 13, 2006
Approved
Brand (NDA)
Application
AP
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 13, 2006
20 yr 6 mo ago
Today
Patent 8415337 expires
Listed drug substance patent expiration.
Mar 02, 2032
in 5 yr 9 mo
Pharmaceutical detail
Active ingredient
IBUPROFEN LYSINE
Strength
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
NDA 021903
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8415337 | Mar 02, 2032 | in 5 yr 9 mo | SubstanceProduct |
