Orange Book product · Brand (NDA)
ATIVAN
LORAZEPAM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
LORAZEPAM
Strength
4MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 018140
Product number
002
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.
- 2021LOREEV XRBrand (NDA)
NDA 214826 · ALMATICA
- —ATIVANBrand (NDA)
NDA 017794 · BAUSCH
- 2025LORAZEPAMGeneric (ANDA)
ANDA 218597 · GRAVITI PHARMS
- 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.
