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Last Updated: April 20, 2024

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. Three suppliers are 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 Action	X-Ray Contrast Activity

Medical Subject Heading (MeSH) Categories for 020327

Contrast Media

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:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	41%
Approval Date:	Oct 12, 1994	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	51%
Approval Date:	Oct 12, 1994	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	61%
Approval Date:	Oct 12, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 020327

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

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