HYDRALAZINE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for hydralazine hydrochloride and what is the scope of freedom to operate?
Hydralazine hydrochloride
is the generic ingredient in twenty-eight branded drugs marketed by Novartis, Abraxis Pharm, Adrastea Pharma, Am Regent, Eugia Pharma, Fresenius Kabi Usa, Hikma, Navinta Llc, Norvium Bioscience, Rising, Smith And Nephew, Solopak, Teva Parenteral, Teva, Actavis Elizabeth, Actavis Grp Ptc, Alkem Labs Ltd, Anda Repository, Ascot, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Halsey, Heritage, Heritage Pharms Inc, Hetero Labs Ltd Iii, Impax Labs, Invagen Pharms, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mutual Pharm, Pliva, Purepac Pharm, Quantum Pharmics, Sciegen Pharms Inc, Strides Pharma, Superpharm, Upsher Smith Labs, Usl Pharma, Vangard, Vitarine, Watson Labs, West Ward, Solvay, Ivax Pharms, Mylan, Sandoz, Sun Pharm Industries, Lederle, Azurity, I3 Pharms, and Riconpharma Llc, and is included in one hundred and twenty-five NDAs. Additional information is available in the individual branded drug profile pages.There are fifteen drug master file entries for hydralazine hydrochloride. Forty-three suppliers are listed for this compound.
Summary for HYDRALAZINE HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 28 |
Applicants: | 52 |
NDAs: | 125 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 43 |
Raw Ingredient (Bulk) Api Vendors: | 118 |
Clinical Trials: | 65 |
Patent Applications: | 1,703 |
Drug Prices: | Drug price trends for HYDRALAZINE HYDROCHLORIDE |
What excipients (inactive ingredients) are in HYDRALAZINE HYDROCHLORIDE? | HYDRALAZINE HYDROCHLORIDE excipients list |
DailyMed Link: | HYDRALAZINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for HYDRALAZINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute for Medical Research Development (NIMAD), Iran | Phase 3 |
McMaster University | Phase 3 |
Shahid Sadoughi University of Medical Sciences and Health Services | Phase 3 |
Pharmacology for HYDRALAZINE HYDROCHLORIDE
Drug Class | Arteriolar Vasodilator |
Physiological Effect | Arteriolar Vasodilation |
Medical Subject Heading (MeSH) Categories for HYDRALAZINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for HYDRALAZINE HYDROCHLORIDE
US Patents and Regulatory Information for HYDRALAZINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pliva | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | TABLET;ORAL | 088467-001 | May 1, 1984 | AA | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Purepac Pharm | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | TABLET;ORAL | 088178-001 | Aug 15, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Mutual Pharm | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | TABLET;ORAL | 084106-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Strides Pharma | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | TABLET;ORAL | 086962-001 | Approved Prior to Jan 1, 1982 | AA | RX | 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 |
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