FDA Orange Book · active-ingredient family
Candesartan cilexetil
Candesartan cilexetil is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ATACAND · NDA 020838
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATACANDRLD×4 | ANI PHARMS | NDA 020838 | AB | Jun 04, 1998 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CANDESARTAN CILEXETIL×3 | PRINSTON INC | ANDA 206233 | AB | Aug 21, 2023 | |
| CANDESARTAN CILEXETIL×3 | ALEMBIC | ANDA 210302 | AB | Dec 04, 2018 | |
| CANDESARTAN CILEXETIL×4 | ZYDUS LIFESCIENCES | ANDA 091390 | AB | Aug 23, 2017 | |
| CANDESARTAN CILEXETIL | ALEMBIC | ANDA 209119 | AB | Jun 20, 2017 | |
| CANDESARTAN CILEXETIL×4 | MACLEODS PHARMS LTD | ANDA 203813 | AB | Dec 05, 2016 | |
| CANDESARTAN CILEXETIL×4 | APOTEX | ANDA 202079 | — | Jan 10, 2014 | |
| CANDESARTAN CILEXETIL×4 | MYLAN | ANDA 078702 | AB | May 03, 2013 |
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
