Orange Book product · Brand (NDA)
ATACAND
CANDESARTAN CILEXETIL
At a glance
Jun 04, 1998
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 04, 1998
28 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
CANDESARTAN CILEXETIL
Strength
4MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020838
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.
- 2023CANDESARTAN CILEXETILGeneric (ANDA)
ANDA 206233 · PRINSTON INC
- 2018CANDESARTAN CILEXETILGeneric (ANDA)
ANDA 210302 · ALEMBIC
- 2017CANDESARTAN CILEXETILGeneric (ANDA)
ANDA 091390 · ZYDUS LIFESCIENCES
- 2017CANDESARTAN CILEXETILGeneric (ANDA)
ANDA 209119 · ALEMBIC
- 2016CANDESARTAN CILEXETILGeneric (ANDA)
ANDA 203813 · MACLEODS PHARMS LTD
- 2014CANDESARTAN CILEXETILGeneric (ANDA)
ANDA 202079 · APOTEX
- 2013CANDESARTAN CILEXETILGeneric (ANDA)
ANDA 078702 · MYLAN
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.
