Orange Book product · Generic (ANDA)
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
At a glance
Sep 25, 2012
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 2012
13 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Strength
EQ 5MG BASE;12.5MG;160MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 200435
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
- 2009EXFORGE HCTBrand (NDA)
NDA 022314 · NOVARTIS
- 2025AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 207299 · MACLEODS PHARMS LTD
- 2017AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 206180 · AUROBINDO PHARMA
- 2015AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 200797 · LUPIN
- 2015AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 201593 · TORRENT
- 2015AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 201087 · 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.
