GUANIDINE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for guanidine hydrochloride and what is the scope of patent protection?
Guanidine hydrochloride
is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for guanidine hydrochloride.
Summary for GUANIDINE HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 176 |
Clinical Trials: | 8 |
Patent Applications: | 318 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in GUANIDINE HYDROCHLORIDE? | GUANIDINE HYDROCHLORIDE excipients list |
DailyMed Link: | GUANIDINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for GUANIDINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Children's Hospital of Fudan University | Phase 4 |
Washington University School of Medicine | Early Phase 1 |
St. Louis University | Early Phase 1 |
US Patents and Regulatory Information for GUANIDINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck Sharp Dohme | GUANIDINE HYDROCHLORIDE | guanidine hydrochloride | TABLET;ORAL | 001546-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |