Orange Book product · Brand (NDA)
DIOVAN HCT
HYDROCHLOROTHIAZIDE; VALSARTAN
At a glance
Mar 06, 1998
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 06, 1998
28 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Strength
12.5MG;80MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020818
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.
- 2026VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 204687 · SCIEGEN PHARMS
- 2023VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 204382 · AMNEAL PHARMS
- 2019VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 203000 · ZYDUS LIFESCIENCES
- 2016VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 206083 · PRINSTON INC
- 2013VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 203145 · MACLEODS PHARMS LTD
- 2013VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 201662 · ALEMBIC
- 2013VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 203026 · APOTEX INC
- 2013VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 202519 · AUROBINDO PHARMA LTD
- 2013VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 078946 · LUPIN LTD
- 2013VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 091519 · WATSON LABS TEVA
- 2012VALSARTAN AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 078020 · MYLAN PHARMS INC
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.
