Orange Book product · Brand (NDA)
BIDIL
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
At a glance
Jun 23, 2005
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 23, 2005
21 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Strength
37.5MG;20MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020727
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
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.
