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Serving leading biopharmaceutical companies globally:

Queensland Health
Daiichi Sankyo
Express Scripts

Generated: December 11, 2017

DrugPatentWatch Database Preview

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

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 0270-1315-30 10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-30) > 50 mL in 1 VIAL, SINGLE-DOSE
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

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
BraccoISOVUE-200iopamidolINJECTABLE;INJECTION020327-001Oct 12, 1994► Subscribe► Subscribe
BraccoISOVUE-370iopamidolINJECTABLE;INJECTION020327-004Oct 12, 1994► Subscribe► Subscribe
BraccoISOVUE-300iopamidolINJECTABLE;INJECTION020327-003Oct 12, 1994► Subscribe► Subscribe
BraccoISOVUE-250iopamidolINJECTABLE;INJECTION020327-002Oct 12, 1994► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health
Chinese Patent Office
Daiichi Sankyo
Queensland Health

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