Orange Book product · Brand (NDA)
AZOR
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
At a glance
Sep 26, 2007
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 26, 2007
19 yr ago
Today
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Strength
EQ 5MG BASE;20MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 022100
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.
- 2025AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 209591 · HETERO LABS LTD V
- 2018AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 209010 · SCIEGEN PHARMS
- 2018AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 209600 · ACCORD HLTHCARE INC
- 2017AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 207435 · MICRO LABS
- 2017AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 207771 · ZYDUS PHARMS
- 2017AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 209042 · ALKEM LABS LTD
- 2017AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 207073 · ALEMBIC
- 2017AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 207807 · GLENMARK PHARMS LTD
- 2017AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 206906 · AUROBINDO PHARMA
- 2017AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 207450 · JUBILANT GENERICS
- 2016AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 202933 · TORRENT
- 2016AMLODIPINE AND OLMESARTAN MEDOXOMILGeneric (ANDA)
ANDA 207216 · AJANTA PHARMA LTD
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.
