Details for New Drug Application (NDA): 050740

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NDA 050740 describes AMBISOME, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. Additional details are available on the AMBISOME profile page.

The generic ingredient in AMBISOME 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 050740

Tradename:	AMBISOME
Applicant:	Astellas
Ingredient:	amphotericin b
Patents:	0

Pharmacology for NDA: 050740

Medical Subject Heading (MeSH) Categories for 050740

Amebicides
Anti-Bacterial Agents
Antifungal Agents
Antiprotozoal Agents

Suppliers and Packaging for NDA: 050740

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740	NDA	Astellas Pharma US, Inc.	0469-3051	0469-3051-30	12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE, LIPOSOMAL;INJECTION			Strength	50MG/VIAL
Approval Date:	Aug 11, 1997	TE:	AB	RLD:	Yes

Expired US Patents for NDA 050740

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997	⤷ Sign Up	⤷ Sign Up
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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