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Generated: November 17, 2018

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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
Formulation / Manufacturing:see details
Pharmacology for NDA: 020123
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 0407-0690-30 10 VIAL in 1 BOX (0407-0690-30) > 10 mL in 1 VIAL
OMNISCAN gadodiamide INJECTABLE;INJECTION 020123 NDA GE Healthcare Inc. 0407-0690 0407-0690-40 10 VIAL in 1 BOX (0407-0690-40) > 15 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength287MG/ML
Approval Date:Jan 8, 1993TE:RLD:Yes

Expired US Patents for NDA 020123

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare OMNISCAN gadodiamide INJECTABLE;INJECTION 020123-001 Jan 8, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Ge Healthcare OMNISCAN gadodiamide INJECTABLE;INJECTION 020123-001 Jan 8, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Ge Healthcare OMNISCAN gadodiamide INJECTABLE;INJECTION 020123-001 Jan 8, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
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