Orange Book product · Brand (NDA)
LANSOPRAZOLE
LANSOPRAZOLE
At a glance
Jun 07, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 07, 2016
10 yr 2 mo ago
Today
Patent 11077055 expires
Listed drug product patent expiration.
Apr 21, 2036
in 10 yr
Patent 11986554 expires
Listed drug product patent expiration.
Apr 21, 2036
in 10 yr
Pharmaceutical detail
Active ingredient
LANSOPRAZOLE
Strength
15MG
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 208025
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2009PREVACID 24 HRBrand (NDA)
NDA 022327 · PERRIGO PHARMA INTL
- 2004PREVACID IVBrand (NDA)
NDA 021566 · TAKEDA PHARMS NA
- 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 (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11077055 | Apr 21, 2036 | in 10 yr | Product |
| 11986554 | Apr 21, 2036 | in 10 yr | Product |

