Orange Book product · Brand (NDA)
APRESOLINE-ESIDRIX
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Strength
25MG;15MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 012026
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1987HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 089200 · SUPERPHARM
- 1987HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 089201 · SUPERPHARM
- 1985HYDRA-ZIDEGeneric (ANDA)
ANDA 088957 · STRIDES PHARMA INTL
- 1985HYDRA-ZIDEGeneric (ANDA)
ANDA 088946 · STRIDES PHARMA INTL
- 1985HYDRA-ZIDEGeneric (ANDA)
ANDA 088961 · STRIDES PHARMA INTL
- 1984HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50Generic (ANDA)
ANDA 088358 · IVAX PHARMS
- 1984HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25Generic (ANDA)
ANDA 088356 · IVAX PHARMS
- 1984HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50Generic (ANDA)
ANDA 088357 · IVAX PHARMS
- 1982HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 085457 · WATSON LABS
- 1982HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 085446 · WATSON LABS
- 1982HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 085440 · WATSON LABS
- 1982HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 087608 · SOLVAY
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.
