Orange Book product · Brand (NDA)
LEVETIRACETAM IN SODIUM CHLORIDE
LEVETIRACETAM
At a glance
Nov 09, 2011
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 09, 2011
14 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVETIRACETAM
Strength
500MG/100ML (5MG/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
NDA 202543
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.
- 2018ELEPSIA XRBrand (NDA)
NDA 204417 · TRIPOINT
- 2008KEPPRA XRBrand (NDA)
NDA 022285 · UCB INC
- 2006KEPPRABrand (NDA)
NDA 021872 · UCB INC
- 2003KEPPRABrand (NDA)
NDA 021505 · UCB INC
- 2026LEVETIRACETAM IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 218364 · MYLAN LABS LTD
- 2025LEVETIRACETAMGeneric (ANDA)
ANDA 215465 · KNACK
- 2025LEVETIRACETAMGeneric (ANDA)
ANDA 218080 · ANDA REPOSITORY
- 2025LEVETIRACETAM IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 219562 · CAPLIN
- 2024LEVETIRACETAM IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 209705 · B BRAUN MEDICAL
- 2024LEVETIRACETAM IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 211356 · HIKMA
- 2023LEVETIRACETAMGeneric (ANDA)
ANDA 214673 · STRIDES PHARMA
- 2023LEVETIRACETAM IN SODIUM CHLORIDEGeneric (ANDA)
ANDA 217059 · BAXTER HLTHCARE CORP
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.
