Orange Book product · Generic (ANDA)
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
At a glance
Nov 27, 2017
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 27, 2017
8 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Strength
16MG;12.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 203466
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
- 2000ATACAND HCTBrand (NDA)
NDA 021093 · ANI PHARMS
- 2018CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 207455 · PRINSTON INC
- 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.
