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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 018735

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NDA 018735 describes ISOVUE-M 300, which is a drug marketed by Bracco and is included in one NDA. It is available from one supplier. Additional details are available on the ISOVUE-M 300 profile page.

The generic ingredient in ISOVUE-M 300 is iopamidol. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iopamidol profile page.
Summary for 018735
Tradename:ISOVUE-M 300
Formulation / Manufacturing:see details
Pharmacology for NDA: 018735
Mechanism of ActionX-Ray Contrast Activity
Medical Subject Heading (MeSH) Categories for 018735
Suppliers and Packaging for NDA: 018735
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOVUE-128 iopamidol INJECTABLE;INJECTION 018735 NDA BRACCO DIAGNOSTICS INC 0270-1314 0270-1314-15 10 BOTTLE in 1 BOX (0270-1314-15) / 200 mL in 1 BOTTLE
ISOVUE-128 iopamidol INJECTABLE;INJECTION 018735 NDA BRACCO DIAGNOSTICS INC 0270-1315 0270-1315-25 10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-25) / 30 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength41%
Approval Date:Dec 31, 1985TE:AP1RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength61%
Approval Date:Dec 31, 1985TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength76%
Approval Date:Dec 31, 1985TE:RLD:Yes

Expired US Patents for NDA 018735

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bracco ISOVUE-370 iopamidol INJECTABLE;INJECTION 018735-003 Dec 31, 1985 ⤷  Try a Trial ⤷  Try a Trial
Bracco ISOVUE-M 200 iopamidol INJECTABLE;INJECTION 018735-001 Dec 31, 1985 ⤷  Try a Trial ⤷  Try a Trial
Bracco ISOVUE-250 iopamidol INJECTABLE;INJECTION 018735-007 Jul 6, 1992 ⤷  Try a Trial ⤷  Try a Trial
Bracco ISOVUE-M 300 iopamidol INJECTABLE;INJECTION 018735-004 Dec 31, 1985 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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