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Colistimethate sodiumis the generic ingredient in two branded drugs marketed by Emcure Pharms Ltd, Fresenius Kabi Usa, Nexus Pharms, Sagent Pharms Inc, Xellia Pharms Aps, Xgen Pharms, and Par Sterile Products, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.
There are two drug master file entries for colistimethate sodium. Seven suppliers are listed for this compound.
Recent Clinical Trials for COLISTIMETHATE SODIUM
Identify potential brand extensions & 505(b)(2) entrants
|Zambon SpA||Phase 3|
|Minsk State Clinical Hospital No 9||Phase 4|
|Belarusian state medical university||Phase 4|
Pharmacology for COLISTIMETHATE SODIUM
|Drug Class||Polymyxin-class Antibacterial |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Fresenius Kabi Usa||COLISTIMETHATE SODIUM||colistimethate sodium||INJECTABLE;INJECTION||065364-001||Apr 17, 2008||AP||RX||No||No||Start Trial||Start Trial||Start Trial|
|Par Sterile Products||COLY-MYCIN M||colistimethate sodium||INJECTABLE;INJECTION||050108-002||Approved Prior to Jan 1, 1982||AP||RX||Yes||Yes||Start Trial||Start Trial||Start Trial|
|Sagent Pharms Inc||COLISTIMETHATE SODIUM||colistimethate sodium||INJECTABLE;INJECTION||201365-001||Feb 19, 2014||AP||RX||No||No||Start Trial||Start Trial||Start Trial|
|Xgen Pharms||COLISTIMETHATE SODIUM||colistimethate sodium||INJECTABLE;INJECTION||064216-001||Feb 26, 1999||AP||RX||No||No||Start Trial||Start Trial||Start Trial|
|Emcure Pharms Ltd||COLISTIMETHATE SODIUM||colistimethate sodium||INJECTABLE;INJECTION||202359-001||Sep 28, 2012||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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