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Last Updated: August 13, 2020

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CEFTRIAXONE SODIUM - Generic Drug Details

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What are the generic drug sources for ceftriaxone sodium and what is the scope of freedom to operate?

Ceftriaxone sodium is the generic ingredient in seven branded drugs marketed by Acs Dobfar, Agila Speclts, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Qilu, Samson Medcl, Sandoz, Sandoz Inc, Teva, Wockhardt, B Braun, Baxter Hlthcare, Astral, Hikma, Hoffmann La Roche, Roche, Akorn Inc, Cephazone Pharma, Hikma Farmaceutica, and Teva Pharms Usa, and is included in forty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for ceftriaxone sodium. Twenty-one suppliers are listed for this compound.

Recent Clinical Trials for CEFTRIAXONE SODIUM

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

SponsorPhase
University of British ColumbiaEarly Phase 1
Fayoum University HospitalPhase 4
Xiangbei Welman Pharmaceutical Co., LtdPhase 4

See all CEFTRIAXONE SODIUM clinical trials

Pharmacology for CEFTRIAXONE SODIUM
Medical Subject Heading (MeSH) Categories for CEFTRIAXONE SODIUM

US Patents and Regulatory Information for CEFTRIAXONE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche ROCEPHIN KIT ceftriaxone sodium; lidocaine INJECTABLE;INJECTION 050585-007 May 8, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Bedford CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065465-003 Aug 18, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Roche ROCEPHIN ceftriaxone sodium INJECTABLE;INJECTION 062510-002 Mar 12, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Astral CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 091049-002 Jun 11, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc CEFTRIAXONE ceftriaxone sodium INJECTABLE;INJECTION 065204-002 May 3, 2005 AP RX No Yes   Start Trial   Start Trial   Start Trial
Astral CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 091049-003 Jun 11, 2018 AP RX 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

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