Orange Book product · Brand (NDA)
EXFORGE
AMLODIPINE BESYLATE; VALSARTAN
At a glance
Jun 20, 2007
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 20, 2007
19 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE; VALSARTAN
Strength
EQ 5MG BASE;160MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021990
Product number
002
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.
- 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
- 2013AMLODIPINE BESYLATE AND VALSARTANGeneric (ANDA)
ANDA 090011 · STRIDES PHARMA INTL
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.
