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

Summary for NDA: 020327


Pharmacology for NDA: 020327

Mechanism of ActionX-Ray Contrast Activity

Suppliers and Packaging for NDA: 020327

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 020327 NDA Bracco Diagnostics Inc 0270-1315 0270-1315-41 10 BOTTLE in 1 BOX (0270-1315-41) > 200 mL in 1 BOTTLE
INJECTABLE;INJECTION 020327 NDA Bracco Diagnostics Inc 0270-1315 0270-1315-98 6 BOTTLE in 1 BOX (0270-1315-98) > 500 mL in 1 BOTTLE

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 020327

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
INJECTABLE;INJECTION020327-001Oct 12, 19944,001,323<disabled>
INJECTABLE;INJECTION020327-003Oct 12, 19944,001,323<disabled>
INJECTABLE;INJECTION020327-004Oct 12, 19944,001,323<disabled>
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