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Generated: November 12, 2018

DrugPatentWatch Database Preview

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 018956
Tradename:OMNIPAQUE 70
Applicant:Ge Healthcare
Ingredient:iohexol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018956
Mechanism of ActionX-Ray Contrast Activity
Medical Subject Heading (MeSH) Categories for 018956
Suppliers and Packaging for NDA: 018956
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OMNIPAQUE 140 iohexol 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
OMNIPAQUE 140 iohexol 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

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Expired US Patents for NDA 018956

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare OMNIPAQUE 180 iohexol SOLUTION;INJECTION, ORAL, RECTAL 018956-001 Dec 26, 1985 ➤ Sign Up ➤ Sign Up
Ge Healthcare OMNIPAQUE 140 iohexol INJECTABLE;INJECTION 018956-005 Nov 30, 1988 ➤ Sign Up ➤ Sign Up
Ge Healthcare OMNIPAQUE 350 iohexol SOLUTION;INJECTION, ORAL 018956-004 Dec 26, 1985 ➤ Sign Up ➤ Sign Up
Ge Healthcare OMNIPAQUE 70 iohexol SOLUTION;URETHRAL 018956-007 Jun 1, 1994 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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