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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 050724

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NDA 050724 describes ABELCET, which is a drug marketed by Leadiant Biosci Inc and is included in one NDA. Additional details are available on the ABELCET profile page.

The generic ingredient in ABELCET is amphotericin b. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.

Summary for 050724

Tradename:	ABELCET
Applicant:	Leadiant Biosci Inc
Ingredient:	amphotericin b
Patents:	0

Medical Subject Heading (MeSH) Categories for 050724

Amebicides
Anti-Bacterial Agents
Antifungal Agents
Antiprotozoal Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE, LIPID COMPLEX;INJECTION			Strength	5MG/ML
Approval Date:	Nov 20, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 050724

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leadiant Biosci Inc	ABELCET	amphotericin b	INJECTABLE, LIPID COMPLEX;INJECTION	050724-001	Nov 20, 1995	5,616,334	⤷ Start Trial
Leadiant Biosci Inc	ABELCET	amphotericin b	INJECTABLE, LIPID COMPLEX;INJECTION	050724-001	Nov 20, 1995	6,406,713	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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