Orange Book product · Generic (ANDA)
AMLODIPINE BESYLATE AND VALSARTAN
AMLODIPINE BESYLATE; VALSARTAN
At a glance
Mar 28, 2013
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 28, 2013
13 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE; VALSARTAN
Strength
EQ 5MG BASE;160MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 090011
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMLODIPINE BESYLATE; VALSARTAN
- 2007EXFORGEBrand (NDA)
NDA 021990 · NOVARTIS
- 2024AMLODIPINE BESYLATE AND VALSARTANGeneric (ANDA)
ANDA 207292 · MACLEODS PHARMS LTD
- 2016AMLODIPINE BESYLATE AND VALSARTANGeneric (ANDA)
ANDA 205137 · HETERO LABS
- 2016AMLODIPINE BESYLATE AND VALSARTANGeneric (ANDA)
ANDA 206512 · AUROBINDO PHARMA
- 2015AMLODIPINE BESYLATE AND VALSARTANGeneric (ANDA)
ANDA 202713 · ALEMBIC
- 2015AMLODIPINE BESYLATE AND VALSARTANGeneric (ANDA)
ANDA 090245 · LUPIN
- 2015AMLODIPINE BESYLATE AND VALSARTANGeneric (ANDA)
ANDA 090483 · MYLAN
- 2015AMLODIPINE BESYLATE AND VALSARTANGeneric (ANDA)
ANDA 202829 · NOVEL LABS INC
- 2015AMLODIPINE BESYLATE AND VALSARTANGeneric (ANDA)
ANDA 091235 · TEVA PHARMS USA
- 2015AMLODIPINE BESYLATE AND VALSARTANGeneric (ANDA)
ANDA 202377 · TORRENT
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.
