CEFOTAXIME SODIUM - Generic Drug Details

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

Cefotaxime sodium is the generic ingredient in seven branded drugs marketed by Fresenius Kabi Usa, Hikma, Wockhardt, B Braun, Aurobindo Pharma, Aurobindo Pharma Ltd, Cephazone Pharma, Hospira, Hospira Inc, Lupin, Sanofi Aventis Us, and Sterimax, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for cefotaxime sodium. One supplier is listed for this compound.

Sponsor	Phase
Fayoum University Hospital	Phase 4
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

Sponsor

Phase

Fayoum University Hospital

Phase 4

Federal University of São Paulo

Phase 4

Fundação de Amparo à Pesquisa do Estado de São Paulo

Phase 4

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sterimax	CLAFORAN	cefotaxime sodium	INJECTABLE;INJECTION	050547-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	CEFOTAXIME SODIUM	cefotaxime sodium	INJECTABLE;INJECTION	065517-002	Nov 6, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira Inc	CEFOTAXIME SODIUM	cefotaxime sodium	INJECTABLE;INJECTION	065293-002	Aug 10, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sterimax	CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cefotaxime sodium	INJECTABLE;INJECTION	050596-003	May 20, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
B Braun	CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER	cefotaxime sodium	INJECTABLE;INJECTION	050792-002	Jul 29, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	CEFOTAXIME SODIUM	cefotaxime sodium	INJECTABLE;INJECTION	065517-001	Nov 6, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	CEFOTAXIME SODIUM	cefotaxime sodium	INJECTABLE;INJECTION	065516-001	Nov 6, 2009		DISCN	No	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

US Patents:	0
Tradenames:	7
Applicants:	12
NDAs:	17
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	8
Patent Applications:	4,230
DailyMed Link:	CEFOTAXIME SODIUM at DailyMed