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Last Updated: July 19, 2024

Bismuth subsalicylate; metronidazole; tetracycline hydrochloride - Generic Drug Details


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What are the generic drug sources for bismuth subsalicylate; metronidazole; tetracycline hydrochloride and what is the scope of freedom to operate?

Bismuth subsalicylate; metronidazole; tetracycline hydrochloride is the generic ingredient in two branded drugs marketed by Nostrum Labs Inc and Casper Pharma Llc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for bismuth subsalicylate; metronidazole; tetracycline hydrochloride
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Clinical Trials: 2
DailyMed Link:bismuth subsalicylate; metronidazole; tetracycline hydrochloride at DailyMed
Recent Clinical Trials for bismuth subsalicylate; metronidazole; tetracycline hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
M.D. Anderson Cancer CenterPhase 2

See all bismuth subsalicylate; metronidazole; tetracycline hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for bismuth subsalicylate; metronidazole; tetracycline hydrochloride

US Patents and Regulatory Information for bismuth subsalicylate; metronidazole; tetracycline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nostrum Labs Inc BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE bismuth subsalicylate; metronidazole; tetracycline hydrochloride TABLET, CHEWABLE, TABLET, CAPSULE;ORAL 202584-001 Nov 30, 2018 RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Casper Pharma Llc HELIDAC bismuth subsalicylate; metronidazole; tetracycline hydrochloride TABLET, CHEWABLE, TABLET, CAPSULE;ORAL 050719-001 Aug 15, 1996 DISCN Yes 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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