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Last Updated: April 20, 2024

Metronidazole hydrochloride - Generic Drug Details


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What are the generic drug sources for metronidazole hydrochloride and what is the scope of patent protection?

Metronidazole hydrochloride is the generic ingredient in two branded drugs marketed by Pfizer and Abraxis Pharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for metronidazole hydrochloride
Recent Clinical Trials for metronidazole hydrochloride

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

SponsorPhase
Ministry of Health, FrancePhase 3
Hôpital Necker-Enfants MaladesPhase 3
Institut PasteurPhase 3

See all metronidazole hydrochloride clinical trials

US Patents and Regulatory Information for metronidazole hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abraxis Pharm METRONIDAZOLE HYDROCHLORIDE metronidazole hydrochloride INJECTABLE;INJECTION 070295-001 Oct 15, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer FLAGYL I.V. metronidazole hydrochloride INJECTABLE;INJECTION 018353-001 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

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