FDA Orange Book · active-ingredient family
Hydralazine hydrochloride; isosorbide dinitrate
Hydralazine hydrochloride; isosorbide dinitrate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BIDIL · NDA 020727
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BIDILRLD | AZURITY | NDA 020727 | AB | Jun 23, 2005 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | I3 PHARMS | ANDA 215988 | AB | Jan 17, 2024 | |
| ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | INGENUS PHARMS LLC | ANDA 215586 | AB | Apr 06, 2022 |
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.
Hydralazine hydrochloride; isosorbide dinitrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
