FDA Orange Book · active-ingredient family
Hydrochlorothiazide; valsartan
Hydrochlorothiazide; valsartan is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DIOVAN HCT · NDA 020818
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIOVAN HCTRLD×5 | NOVARTIS | NDA 020818 | AB | Mar 06, 1998 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | SCIEGEN PHARMS | ANDA 204687 | AB | Apr 23, 2026 | |
| VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | AMNEAL PHARMS | ANDA 204382 | AB | Aug 11, 2023 | |
| VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | ZYDUS LIFESCIENCES | ANDA 203000 | — | Mar 15, 2019 | |
| VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | PRINSTON INC | ANDA 206083 | AB | Feb 08, 2016 | |
| VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | MACLEODS PHARMS LTD | ANDA 203145 | AB | Apr 19, 2013 | |
| VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | ALEMBIC | ANDA 201662 | AB | Mar 21, 2013 | |
| VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | APOTEX INC | ANDA 203026 | — | Mar 21, 2013 | |
| VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | AUROBINDO PHARMA LTD | ANDA 202519 | AB | Mar 21, 2013 | |
| VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | LUPIN LTD | ANDA 078946 | — | Mar 21, 2013 | |
| VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | WATSON LABS TEVA | ANDA 091519 | — | Mar 21, 2013 | |
| VALSARTAN AND HYDROCHLOROTHIAZIDE×5 | MYLAN PHARMS INC | ANDA 078020 | AB | Sep 21, 2012 |
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.
Hydrochlorothiazide; valsartan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
