FDA Orange Book · active-ingredient family
Candesartan cilexetil; hydrochlorothiazide
Candesartan cilexetil; hydrochlorothiazide is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ATACAND HCT · NDA 021093
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATACAND HCTRLD×3 | ANI PHARMS | NDA 021093 | AB | Sep 05, 2000 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE×3 | PRINSTON INC | ANDA 207455 | AB | Apr 11, 2018 | |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE×3 | ZYDUS LIFESCIENCES | ANDA 203466 | AB | Nov 27, 2017 | |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE×3 | MACLEODS PHARMS LTD | ANDA 204100 | AB | Feb 27, 2015 | |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE×3 | SENORES PHARMS | ANDA 202965 | AB | Jun 03, 2013 | |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE×3 | APOTEX INC | ANDA 202884 | — | Dec 04, 2012 | |
| CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE×3 | PHARMOBEDIENT | ANDA 090704 | AB | Dec 04, 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.
Candesartan cilexetil; hydrochlorothiazide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
