Hydralazine hydrochloride; reserpine - Generic Drug Details
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What are the generic sources for hydralazine hydrochloride; reserpine and what is the scope of patent protection?
Hydralazine hydrochloride; reserpine
is the generic ingredient in two branded drugs marketed by Sandoz and Novartis, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.Summary for hydralazine hydrochloride; reserpine
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Clinical Trials: | 2 |
DailyMed Link: | hydralazine hydrochloride; reserpine at DailyMed |
Recent Clinical Trials for hydralazine hydrochloride; reserpine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
VA Office of Research and Development | |
US Department of Veterans Affairs | |
National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 |
See all hydralazine hydrochloride; reserpine clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for hydralazine hydrochloride; reserpine
US Patents and Regulatory Information for hydralazine hydrochloride; reserpine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | SERPASIL-APRESOLINE | hydralazine hydrochloride; reserpine | TABLET;ORAL | 009296-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | SERPASIL-APRESOLINE | hydralazine hydrochloride; reserpine | TABLET;ORAL | 009296-004 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sandoz | DRALSERP | hydralazine hydrochloride; reserpine | TABLET;ORAL | 084617-001 | 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 |