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. It is available from one supplier. 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. Five 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

Pharmacology for NDA: 050724

Medical Subject Heading (MeSH) Categories for 050724

Amebicides
Anti-Bacterial Agents
Antifungal Agents
Antiprotozoal Agents

Suppliers and Packaging for NDA: 050724

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABELCET	amphotericin b	INJECTABLE, LIPID COMPLEX;INJECTION	050724	NDA	Leadiant Biosciences, Inc.	57665-101	57665-101-41	1 VIAL in 1 CARTON (57665-101-41) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	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	⤷ Sign Up	⤷ Sign Up
Leadiant Biosci Inc	ABELCET	amphotericin b	INJECTABLE, LIPID COMPLEX;INJECTION	050724-001	Nov 20, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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