Orange Book product · Brand (NDA)
PREVACID IV
LANSOPRAZOLE
At a glance
May 27, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 27, 2004
22 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
LANSOPRAZOLE
Strength
30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 021566
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2016LANSOPRAZOLEBrand (NDA)
NDA 208025 · DEXCEL
- 2009PREVACID 24 HRBrand (NDA)
NDA 022327 · PERRIGO PHARMA INTL
- 2002PREVACIDBrand (NDA)
NDA 021428 · TAKEDA PHARMS USA
- 2001PREVACIDBrand (NDA)
NDA 021281 · TAKEDA PHARMS NA
- 1995PREVACIDBrand (NDA)
NDA 020406 · TAKEDA PHARMS USA
- 2024LANSOPRAZOLEGeneric (ANDA)
ANDA 208671 · MACLEODS PHARMS LTD
- 2023LANSOPRAZOLEGeneric (ANDA)
ANDA 207167 · AUROBINDO PHARMA LTD
- 2021LANSOPRAZOLEGeneric (ANDA)
ANDA 210465 · DR REDDYS
- 2020LANSOPRAZOLEGeneric (ANDA)
ANDA 203083 · HETERO LABS LTD III
- 2019LANSOPRAZOLEGeneric (ANDA)
ANDA 207394 · ALKEM LABS LTD
- 2018LANSOPRAZOLEGeneric (ANDA)
ANDA 202396 · MYLAN
- 2018LANSOPRAZOLEGeneric (ANDA)
ANDA 200816 · ZYDUS 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.
