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Details for Generic Name: amphotericin b

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Amphotericin b is the generic ingredient in five branded drugs marketed by Apothecon, Sigma Tau, Alkopharma Usa, Astellas, Abbott, Abraxis Pharm, Teva Parenteral, X Gen Pharms, and Bristol Myers Squibb, and is included in twelve NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for amphotericin b. Three suppliers are listed for this compound.

Summary for Generic Name: amphotericin b

Drug Master File Entries: see list15
Suppliers: see list3
Formulation / Manufacturing:see details

Pharmacology for Ingredient: amphotericin b

Clinical Trials for: amphotericin b

To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar
Status: Completed Condition: Leishmaniasis, Visceral

Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis
Status: Completed Condition: Visceral Leishmaniasis

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abraxis Pharm
amphotericin b
INJECTABLE;INJECTION062728-001Apr 13, 1987DISCNNo<disabled><disabled>
amphotericin b
INJECTABLE;INJECTION064141-001Dec 23, 1996DISCNNo<disabled><disabled>
Sigma Tau
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050724-001Nov 20, 1995RXYes6,406,713<disabled>Y<disabled>
amphotericin b
INJECTABLE;INJECTION060517-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
X Gen Pharms
amphotericin b
INJECTABLE;INJECTION063206-001Apr 29, 1992RXYes<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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