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 one supplier. 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. Three 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

Pharmacology for NDA: 018735

Mechanism of Action	X-Ray Contrast Activity

Medical Subject Heading (MeSH) Categories for 018735

Contrast Media

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	0270-1314	0270-1314-15	10 BOTTLE in 1 BOX (0270-1314-15) / 200 mL in 1 BOTTLE
ISOVUE-128	iopamidol	INJECTABLE;INJECTION	018735	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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	41%
Approval Date:	Dec 31, 1985	TE:	AP1	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	61%
Approval Date:	Dec 31, 1985	TE:	AP	RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 10, 2028
Regulatory Exclusivity Use:	FOR ORAL ADMINISTRATION TO DELINEATE THE GASTROINTESTINAL TRACT ON COMPUTED TOMOGRAPHY OF THE ABDOMEN AND PELVIS IN ADULT AND PEDIATRIC PATIENTS

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	76%
Approval Date:	Dec 31, 1985	TE:	AP	RLD:	Yes
Regulatory Exclusivity Expiration:	Oct 10, 2028
Regulatory Exclusivity Use:	FOR ORAL ADMINISTRATION TO DELINEATE THE GASTROINTESTINAL TRACT ON COMPUTED TOMOGRAPHY OF THE ABDOMEN AND PELVIS IN ADULT AND PEDIATRIC PATIENTS

Expired US Patents for NDA 018735

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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-M 300	iopamidol	INJECTABLE;INJECTION	018735-004	Dec 31, 1985	⤷ Start Trial	⤷ Start Trial
Bracco	ISOVUE-370	iopamidol	INJECTABLE;INJECTION	018735-003	Dec 31, 1985	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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