Hydralazine hydrochloride; hydrochlorothiazide; reserpine - Generic Drug Details
What are the generic drug sources for hydralazine hydrochloride; hydrochlorothiazide; reserpine and what is the scope of freedom to operate?
Hydralazine hydrochloride; hydrochlorothiazide; reserpine
is the generic ingredient in twelve branded drugs marketed by Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Watson Labs, Sandoz, Solvay, Sun Pharm Industries, Lederle, and Novartis, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.Summary for hydralazine hydrochloride; hydrochlorothiazide; reserpine
| US Patents: | 0 |
| Tradenames: | 12 |
| Applicants: | 9 |
| NDAs: | 16 |
| Clinical Trials: | 1 |
| DailyMed Link: | hydralazine hydrochloride; hydrochlorothiazide; reserpine at DailyMed |
Recent Clinical Trials for hydralazine hydrochloride; hydrochlorothiazide; reserpine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| VA Office of Research and Development | |
| US Department of Veterans Affairs |
See all hydralazine hydrochloride; hydrochlorothiazide; reserpine clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for hydralazine hydrochloride; hydrochlorothiazide; reserpine
US Patents and Regulatory Information for hydralazine hydrochloride; hydrochlorothiazide; reserpine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ivax Sub Teva Pharms | HYDROSERPINE PLUS (R-H-H) | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 083877-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mylan | HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 087085-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Sun Pharm Industries | RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 088570-001 | Apr 10, 1984 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Novartis | SER-AP-ES | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 012193-005 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Sandoz | HYDRAP-ES | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 084876-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Watson Labs | RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 085549-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Solvay | RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 088376-001 | Oct 28, 1983 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
