Hydralazine hydrochloride; hydrochlorothiazide - Generic Drug Details
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What are the generic sources for hydralazine hydrochloride; hydrochlorothiazide and what is the scope of freedom to operate?
Hydralazine hydrochloride; hydrochlorothiazide
is the generic ingredient in twenty-one branded drugs marketed by Novartis, Strides Pharma Intl, Solvay, Superpharm, Watson Labs, Ivax Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Sandoz, Sun Pharm Industries, and Lederle, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.Summary for hydralazine hydrochloride; hydrochlorothiazide
| US Patents: | 0 |
| Tradenames: | 21 |
| Applicants: | 12 |
| NDAs: | 36 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 3 |
| DailyMed Link: | hydralazine hydrochloride; hydrochlorothiazide at DailyMed |
Recent Clinical Trials for hydralazine hydrochloride; hydrochlorothiazide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vanderbilt University Medical Center | Phase 4 |
| National Center for Research Resources (NCRR) | Phase 4 |
| Vanderbilt University Medical Center | Phase 1 |
See all hydralazine hydrochloride; hydrochlorothiazide clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for hydralazine hydrochloride; hydrochlorothiazide
US Patents and Regulatory Information for hydralazine hydrochloride; hydrochlorothiazide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Solvay | UNIPRES | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 086298-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Superpharm | HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | hydralazine hydrochloride; hydrochlorothiazide | CAPSULE;ORAL | 089200-001 | Feb 9, 1987 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Watson Labs | RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | hydralazine hydrochloride; hydrochlorothiazide; reserpine | TABLET;ORAL | 087556-001 | Approved Prior to Jan 1, 1982 | 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 |
