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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 214010

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NDA 214010 describes AMPHOTERICIN B, which is a drug marketed by Eugia Pharma, Spil, Abbott, Abraxis Pharm, Teva Parenteral, and Xgen Pharms, and is included in six NDAs. It is available from three suppliers. Additional details are available on the AMPHOTERICIN B profile page.

The generic ingredient in AMPHOTERICIN B 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 214010

Tradename:	AMPHOTERICIN B
Applicant:	Eugia Pharma
Ingredient:	amphotericin b
Patents:	0

Pharmacology for NDA: 214010

Medical Subject Heading (MeSH) Categories for 214010

Amebicides
Anti-Bacterial Agents
Antifungal Agents
Antiprotozoal Agents

Suppliers and Packaging for NDA: 214010

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMPHOTERICIN B	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	214010	ANDA	Eugia US LLC	55150-365	55150-365-01	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-365-01) / 12.5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE, LIPOSOMAL;INJECTION			Strength	50MG/VIAL
Approval Date:	Nov 17, 2022	TE:	AB	RLD:	No

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