Details for New Drug Application (NDA): 020899

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NDA 020899 describes OPTISON, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. Additional details are available on the OPTISON profile page.

The generic ingredient in OPTISON is albumin human. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the albumin human profile page.

Summary for 020899

Tradename:	OPTISON
Applicant:	Ge Healthcare
Ingredient:	albumin human
Patents:	0

Pharmacology for NDA: 020899

Mechanism of Action	Ultrasound Contrast Activity

Suppliers and Packaging for NDA: 020899

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OPTISON	albumin human	INJECTABLE;INJECTION	020899	NDA	GE Healthcare Inc.	0407-2707	0407-2707-03	5 VIAL, SINGLE-USE in 1 CARTON (0407-2707-03) / 3 mL in 1 VIAL, SINGLE-USE
OPTISON	albumin human	INJECTABLE;INJECTION	020899	NDA	GE Healthcare Inc.	0407-2707	0407-2707-18	18 VIAL, SINGLE-USE in 1 CARTON (0407-2707-18) / 3 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Dec 31, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020899

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997	⤷ Sign Up	⤷ Sign Up
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997	⤷ Sign Up	⤷ Sign Up
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997	⤷ Sign Up	⤷ Sign Up
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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