FDA Orange Book · active-ingredient family
Hydralazine hydrochloride; hydrochlorothiazide
Hydralazine hydrochloride; hydrochlorothiazide is approved as 1 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:APRESOLINE-ESIDRIX · NDA 012026
1
Brand (NDA)
19
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| APRESOLINE-ESIDRIX | NOVARTIS | NDA 012026 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (19)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | SUPERPHARM | ANDA 089200 | — | Feb 09, 1987 | |
| HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | SUPERPHARM | ANDA 089201 | — | Feb 09, 1987 | |
| HYDRA-ZIDE | STRIDES PHARMA INTL | ANDA 088957 | — | Oct 21, 1985 | |
| HYDRA-ZIDE | STRIDES PHARMA INTL | ANDA 088946 | — | Oct 21, 1985 | |
| HYDRA-ZIDE | STRIDES PHARMA INTL | ANDA 088961 | — | Oct 21, 1985 | |
| HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50 | IVAX PHARMS | ANDA 088358 | — | Apr 10, 1984 | |
| HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25 | IVAX PHARMS | ANDA 088356 | — | Apr 10, 1984 | |
| HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50 | IVAX PHARMS | ANDA 088357 | — | Apr 10, 1984 | |
| HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 085457 | — | Mar 04, 1982 | |
| HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 085446 | — | Mar 04, 1982 | |
| HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 085440 | — | Mar 04, 1982 | |
| HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | SOLVAY | ANDA 087608 | — | Feb 08, 1982 | |
| HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | SOLVAY | ANDA 087213 | — | Feb 08, 1982 | |
| HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | SOLVAY | ANDA 087609 | — | Feb 08, 1982 | |
| APRESAZIDERLD | NOVARTIS | ANDA 084735 | — | Approved Prior to Jan 1, 1982 | |
| APRESAZIDERLD | NOVARTIS | ANDA 084810 | — | Approved Prior to Jan 1, 1982 | |
| APRESAZIDE | NOVARTIS | ANDA 084811 | — | Approved Prior to Jan 1, 1982 | |
| HYDRALAZINE AND HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 085827 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ HYDRALAZINE | WATSON LABS | ANDA 085373 | — | Approved Prior to Jan 1, 1982 |
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; hydrochlorothiazide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
