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Generated: November 17, 2018

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Details for New Drug Application (NDA): 020327

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NDA 020327 describes ISOVUE-370, which is a drug marketed by Bracco and is included in two NDAs. It is available from one supplier. Additional details are available on the ISOVUE-370 profile page.

The generic ingredient in ISOVUE-370 is iopamidol. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iopamidol profile page.
Summary for 020327
Tradename:ISOVUE-370
Applicant:Bracco
Ingredient:iopamidol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020327
Mechanism of ActionX-Ray Contrast Activity
Medical Subject Heading (MeSH) Categories for 020327
Suppliers and Packaging for NDA: 020327
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ISOVUE-200 iopamidol INJECTABLE;INJECTION 020327 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
ISOVUE-200 iopamidol INJECTABLE;INJECTION 020327 NDA Bracco Diagnostics Inc 0270-1315 0270-1315-30 10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-30) > 50 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength41%
Approval Date:Oct 12, 1994TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength51%
Approval Date:Oct 12, 1994TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength61%
Approval Date:Oct 12, 1994TE:RLD:Yes

Expired US Patents for NDA 020327

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bracco ISOVUE-200 iopamidol INJECTABLE;INJECTION 020327-001 Oct 12, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Bracco ISOVUE-370 iopamidol INJECTABLE;INJECTION 020327-004 Oct 12, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Bracco ISOVUE-300 iopamidol INJECTABLE;INJECTION 020327-003 Oct 12, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Fish and Richardson
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Argus Health
Citi

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