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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 NDA: 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 0407-0690-05 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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020123

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare
OMNISCAN
gadodiamide
INJECTABLE;INJECTION020123-001Jan 8, 19934,687,659► subscribe
Ge Healthcare
OMNISCAN
gadodiamide
INJECTABLE;INJECTION020123-001Jan 8, 19935,560,903► subscribe
Ge Healthcare
OMNISCAN
gadodiamide
INJECTABLE;INJECTION020123-001Jan 8, 19935,362,475► subscribe
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