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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 two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the iopamidol profile page.

Summary for NDA: 018735

Formulation / Manufacturing:see details

Pharmacology for NDA: 018735

Mechanism of ActionX-Ray Contrast Activity

Suppliers and Packaging for NDA: 018735

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
INJECTABLE;INJECTION 018735 NDA BRACCO DIAGNOSTICS INC 0270-1314 0270-1314-30 10 VIAL, SINGLE-DOSE in 1 BOX (0270-1314-30) > 50 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 018735

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
INJECTABLE;INJECTION018735-007Jul 6, 19924,001,323► subscribe
INJECTABLE;INJECTION018735-001Dec 31, 19854,001,323► subscribe
INJECTABLE;INJECTION018735-004Dec 31, 19854,001,323► subscribe
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