Orange Book product · Brand (NDA)
EXFORGE HCT
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
At a glance
Apr 30, 2009
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 30, 2009
17 yr 5 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
AB
Application
NDA 022314
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 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
- 2012AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 200435 · 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.
