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Details for New Drug Application (NDA): 018956

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NDA 018956 describes OMNIPAQUE 70, 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 OMNIPAQUE 70 profile page.

The generic ingredient in OMNIPAQUE 70 is iohexol. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iohexol profile page.

Summary for NDA: 018956

Ge Healthcare
Formulation / Manufacturing:see details

Pharmacology for NDA: 018956

Mechanism of ActionX-Ray Contrast Activity

Suppliers and Packaging for NDA: 018956

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 018956 NDA GE Healthcare Inc. 0407-1401 0407-1401-52 10 BOTTLE, PLASTIC in 1 BOX (0407-1401-52) > 50 mL in 1 BOTTLE, PLASTIC
INJECTABLE;INJECTION 018956 NDA GE Healthcare Inc. 0407-1411 0407-1411-10 10 VIAL, GLASS in 1 BOX (0407-1411-10) > 10 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTION, ORAL, RECTALStrength38.8%
Approval Date:Dec 26, 1985TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTION, ORAL, RECTALStrength51.8%
Approval Date:Dec 26, 1985TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTION, ORAL, RECTALStrength64.7%
Approval Date:Dec 26, 1985TE:RLD:Yes

Expired Orange Book Patents for NDA: 018956

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare
SOLUTION;INJECTION, ORAL, RECTAL018956-003Dec 26, 19854,396,597► subscribe
Ge Healthcare
SOLUTION;INJECTION, ORAL, RECTAL018956-001Dec 26, 19854,250,113► subscribe
Ge Healthcare
INJECTABLE;INJECTION018956-005Nov 30, 19884,021,481► subscribe
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