Orange Book product · Generic (ANDA)
LEVETIRACETAM
LEVETIRACETAM
At a glance
Mar 20, 2018
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 20, 2018
8 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVETIRACETAM
Strength
500MG/5ML (100MG/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
ANDA 209781
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LEVETIRACETAM
- 2018ELEPSIA XRBrand (NDA)
NDA 204417 · TRIPOINT
- 2011LEVETIRACETAM IN SODIUM CHLORIDEBrand (NDA)
NDA 202543 · HQ SPCLT PHARMA
- 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
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.
