Orange Book product · Generic (ANDA)
LORAZEPAM
LORAZEPAM
At a glance
Jul 24, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
LORAZEPAM
Strength
0.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 218597
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LORAZEPAM
- 2021LOREEV XRBrand (NDA)
NDA 214826 · ALMATICA
- —ATIVANBrand (NDA)
NDA 018140 · HIKMA
- —ATIVANBrand (NDA)
NDA 017794 · BAUSCH
- 2024LORAZEPAMGeneric (ANDA)
ANDA 217598 · FRESENIUS KABI USA
- 2017LORAZEPAMGeneric (ANDA)
ANDA 203572 · AUROBINDO PHARMA
- 2017LORAZEPAMGeneric (ANDA)
ANDA 200542 · RISING
- 2017LORAZEPAMGeneric (ANDA)
ANDA 200217 · RISING
- 2013LORAZEPAMGeneric (ANDA)
ANDA 091407 · LUPIN LTD
- 2012LORAZEPAMGeneric (ANDA)
ANDA 200169 · HIKMA
- 2010LORAZEPAMGeneric (ANDA)
ANDA 078826 · AMNEAL PHARMS
- 2010LORAZEPAMGeneric (ANDA)
ANDA 090260 · PHARM ASSOC
- 2009LORAZEPAMGeneric (ANDA)
ANDA 091383 · AMNEAL PHARMS
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.
