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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.
Summary for ceftriaxone sodium
US Patents: | 0 |
Tradenames: | 7 |
Applicants: | 24 |
NDAs: | 41 |
Drug Master File Entries: | 26 |
Suppliers / Packagers: | 21 |
Bulk Api Vendors: | 81 |
Clinical Trials: | 16 |
Patent Applications: | 7,402 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ceftriaxone sodium at DailyMed |
Recent Clinical Trials for ceftriaxone sodium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of British Columbia | Early Phase 1 |
Fayoum University Hospital | Phase 4 |
Xiangbei Welman Pharmaceutical Co., Ltd | Phase 4 |
Pharmacology for ceftriaxone sodium
Drug Class | Cephalosporin Antibacterial |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065169-003 | May 9, 2005 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
Hoffmann La Roche | ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER | ceftriaxone sodium | INJECTABLE;INJECTION | 050624-003 | Feb 11, 1987 | DISCN | Yes | 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 | |||
Facta Farma | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065268-002 | Feb 28, 2007 | DISCN | 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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