Orange Book product · Brand (NDA)
PREVACID
LANSOPRAZOLE
At a glance
Aug 30, 2002
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 2002
24 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
LANSOPRAZOLE
Strength
15MG
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021428
Product number
001
Marketing status
RX
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
- 2004PREVACID IVBrand (NDA)
NDA 021566 · TAKEDA PHARMS NA
- 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.
