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Generated: April 20, 2019

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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. There is one patent protecting this drug. 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. Three suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.
Summary for 050724
Applicant:Leadiant Biosci Inc
Ingredient:amphotericin b
Formulation / Manufacturing:see details
Pharmacology for NDA: 050724
Medical Subject Heading (MeSH) Categories for 050724
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

Approval Date:Nov 20, 1995TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 18, 2019Product Flag?Substance Flag?YDelist Request?

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