Orange Book product · Generic (ANDA)
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
At a glance
Jul 05, 2011
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 05, 2011
15 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Strength
EQ 5MG BASE;40MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 090149
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; BENAZEPRIL HYDROCHLORIDE
- 1995LOTRELBrand (NDA)
NDA 020364 · SANDOZ
- 2018AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEGeneric (ANDA)
ANDA 077215 · AMNEAL
- 2013AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEGeneric (ANDA)
ANDA 091431 · HERITAGE
- 2012AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEGeneric (ANDA)
ANDA 202239 · AUROBINDO PHARMA LTD
- 2011AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEGeneric (ANDA)
ANDA 079047 · PHARMOBEDIENT
- 2011AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEGeneric (ANDA)
ANDA 090364 · WATSON LABS INC
- 2010AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEGeneric (ANDA)
ANDA 077890 · WATSON LABS
- 2010AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEGeneric (ANDA)
ANDA 078381 · CHARTWELL RX
- 2010AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEGeneric (ANDA)
ANDA 077375 · RISING
- 2010AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEGeneric (ANDA)
ANDA 077183 · DR REDDYS LABS INC
- 2010AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEGeneric (ANDA)
ANDA 078466 · LUPIN PHARMS
- 2007AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEGeneric (ANDA)
ANDA 077179 · TEVA 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.
