Orange Book product · Generic (ANDA)
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Generic (ANDA)ANDA 215586TE ABRX INGENUS PHARMS LLC
At a glance
Apr 06, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 06, 2022
4 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Strength
37.5MG;20MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 215586
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
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.
