Orange Book product · Brand (NDA)
ATACAND HCT
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
At a glance
Sep 05, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 05, 2000
26 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Strength
16MG;12.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021093
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.
- 2018CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 207455 · PRINSTON INC
- 2017CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 203466 · ZYDUS LIFESCIENCES
- 2015CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 204100 · MACLEODS PHARMS LTD
- 2013CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 202965 · SENORES PHARMS
- 2012CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 202884 · APOTEX INC
- 2012CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 090704 · PHARMOBEDIENT
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.
