Details for New Drug Application (NDA): 020123

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NDA 020123 describes OMNISCAN, which is a drug marketed by Ge Healthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the OMNISCAN profile page.

The generic ingredient in OMNISCAN is gadodiamide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadodiamide profile page.

Summary for 020123

Tradename:	OMNISCAN
Applicant:	Ge Healthcare
Ingredient:	gadodiamide
Patents:	0

Pharmacology for NDA: 020123

Mechanism of Action	Magnetic Resonance Contrast Activity

Suppliers and Packaging for NDA: 020123

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123	NDA	GE Healthcare Inc.	0407-0690	0407-0690-05	10 VIAL in 1 BOX (0407-0690-05) / 5 mL in 1 VIAL
OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123	NDA	GE Healthcare Inc.	0407-0690	0407-0690-10	10 VIAL in 1 BOX (0407-0690-10) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	287MG/ML
Approval Date:	Jan 8, 1993	TE:		RLD:	Yes

Expired US Patents for NDA 020123

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993	⤷ Sign Up	⤷ Sign Up
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993	⤷ Sign Up	⤷ Sign Up
Ge Healthcare	OMNISCAN	gadodiamide	INJECTABLE;INJECTION	020123-001	Jan 8, 1993	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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