Details for New Drug Application (NDA): 020808
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NDA 020808 describes VISIPAQUE 320, which is a drug marketed by Ge Healthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the VISIPAQUE 320 profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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 | 0407-2223-62 | 10 BOTTLE, PLASTIC in 1 BOX (0407-2223-62) / 50 mL in 1 BOTTLE, PLASTIC |
| VISIPAQUE 270 | iodixanol | INJECTABLE;INJECTION | 020808 | NDA | GE Healthcare Inc. | 0407-2223 | 0407-2223-64 | 10 BOTTLE, PLASTIC in 1 BOX (0407-2223-64) / 100 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ge Healthcare | VISIPAQUE 270 | iodixanol | INJECTABLE;INJECTION | 020808-001 | Aug 29, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ge Healthcare | VISIPAQUE 270 | iodixanol | INJECTABLE;INJECTION | 020808-001 | Aug 29, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ge Healthcare | VISIPAQUE 270 | iodixanol | INJECTABLE;INJECTION | 020808-001 | Aug 29, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ge Healthcare | VISIPAQUE 320 | iodixanol | INJECTABLE;INJECTION | 020808-002 | Aug 29, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Ge Healthcare | VISIPAQUE 320 | iodixanol | INJECTABLE;INJECTION | 020808-002 | Aug 29, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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