FDA Orange Book · active-ingredient family
Hydralazine hydrochloride; hydrochlorothiazide; reserpine
Hydralazine hydrochloride; hydrochlorothiazide; reserpine is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SER-AP-ES · NDA 012193
1
Brand (NDA)
15
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SER-AP-ES | NOVARTIS | NDA 012193 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | SUN PHARM INDUSTRIES | ANDA 088570 | — | Apr 10, 1984 | |
| RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | SOLVAY | ANDA 088376 | — | Oct 28, 1983 | |
| RESERPINE, HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDE | LEDERLE | ANDA 087709 | — | May 13, 1982 | |
| CAM-AP-ES | CHARTWELL RX | ANDA 084897 | — | Approved Prior to Jan 1, 1982 | |
| HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE | IVAX SUB TEVA PHARMS | ANDA 084291 | — | Approved Prior to Jan 1, 1982 | |
| HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE | MYLAN | ANDA 087085 | — | Approved Prior to Jan 1, 1982 | |
| HYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINE | WATSON LABS | ANDA 085771 | — | Approved Prior to Jan 1, 1982 | |
| HYDRAP-ES | SANDOZ | ANDA 084876 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE | WATSON LABS | ANDA 083770 | — | Approved Prior to Jan 1, 1982 | |
| HYDROSERPINE PLUS (R-H-H) | IVAX SUB TEVA PHARMS | ANDA 083877 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 085549 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 087556 | — | Approved Prior to Jan 1, 1982 | |
| SER-A-GEN | SOLVAY | ANDA 087210 | — | Approved Prior to Jan 1, 1982 | |
| UNIPRES | SOLVAY | ANDA 085893 | — | Approved Prior to Jan 1, 1982 | |
| UNIPRES | SOLVAY | ANDA 086298 | — | 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; reserpine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
