Hydralazine hydrochloride; hydrochlorothiazide; reserpine - Generic Drug Details
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 085549-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm Industries | RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 088570-001 | Apr 10, 1984 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 083770-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Solvay | RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 088376-001 | Oct 28, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ivax Sub Teva Pharms | HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 084291-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 087085-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Solvay | UNIPRES | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 086298-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
