Details for New Drug Application (NDA): 020808
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The generic ingredient in VISIPAQUE 320 is iodixanol. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iodixanol profile page.
Summary for 020808
Tradename: | VISIPAQUE 320 |
Applicant: | Ge Healthcare |
Ingredient: | iodixanol |
Patents: | 0 |
Pharmacology for NDA: 020808
Mechanism of Action | X-Ray Contrast Activity |
Suppliers and Packaging for NDA: 020808
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VISIPAQUE 270 | iodixanol | INJECTABLE;INJECTION | 020808 | NDA | GE Healthcare Inc. | 0407-2223 | 0407-2223-23 | 10 BOTTLE, PLASTIC in 1 BOX (0407-2223-23) / 500 mL in 1 BOTTLE, PLASTIC |
VISIPAQUE 270 | iodixanol | INJECTABLE;INJECTION | 020808 | NDA | GE Healthcare Inc. | 0407-2223 | 0407-2223-16 | 10 BOTTLE, PLASTIC in 1 BOX (0407-2223-16) / 50 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 55% | ||||
Approval Date: | Aug 29, 1997 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 65.2% | ||||
Approval Date: | Aug 29, 1997 | TE: | RLD: | No |
Expired US Patents for NDA 020808
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ge Healthcare | VISIPAQUE 270 | iodixanol | INJECTABLE;INJECTION | 020808-001 | Aug 29, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VISIPAQUE 270 | iodixanol | INJECTABLE;INJECTION | 020808-001 | Aug 29, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VISIPAQUE 270 | iodixanol | INJECTABLE;INJECTION | 020808-001 | Aug 29, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VISIPAQUE 320 | iodixanol | INJECTABLE;INJECTION | 020808-002 | Aug 29, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VISIPAQUE 320 | iodixanol | INJECTABLE;INJECTION | 020808-002 | Aug 29, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | VISIPAQUE 320 | iodixanol | INJECTABLE;INJECTION | 020808-002 | Aug 29, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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