Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Baxter
Harvard Business School
McKesson
Johnson and Johnson

Last Updated: November 17, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018735

See Plans and Pricing

« Back to Dashboard

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 018735
Tradename:ISOVUE-M 300
Applicant:Bracco
Ingredient:iopamidol
Patents:0
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 0270-1411 0270-1411-11 10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1411-11) > 10 mL in 1 VIAL, SINGLE-DOSE
ISOVUE-128 iopamidol INJECTABLE;INJECTION 018735 NDA Bracco Diagnostics Inc 0270-1411 0270-1411-25 10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1411-25) > 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Expired US Patents for NDA 018735

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bracco ISOVUE-250 iopamidol INJECTABLE;INJECTION 018735-007 Jul 6, 1992   Start Trial   Start Trial
Bracco ISOVUE-M 200 iopamidol INJECTABLE;INJECTION 018735-001 Dec 31, 1985   Start Trial   Start Trial
Bracco ISOVUE-370 iopamidol INJECTABLE;INJECTION 018735-003 Dec 31, 1985   Start Trial   Start Trial
Bracco ISOVUE-300 iopamidol INJECTABLE;INJECTION 018735-002 Dec 31, 1985   Start Trial   Start Trial
Bracco ISOVUE-M 300 iopamidol INJECTABLE;INJECTION 018735-004 Dec 31, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Merck
Medtronic
Dow
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.