Details for New Drug Application (NDA): 020608
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NDA 020608 describes OMNIPAQUE 300, which is a drug marketed by Ge Healthcare and is included in two NDAs. It is available from two suppliers. Additional details are available on the OMNIPAQUE 300 profile page.
The generic ingredient in OMNIPAQUE 300 is iohexol. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iohexol profile page.
The generic ingredient in OMNIPAQUE 300 is iohexol. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iohexol profile page.
Summary for 020608
| Tradename: | OMNIPAQUE 300 |
| Applicant: | Ge Healthcare |
| Ingredient: | iohexol |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020608
| Mechanism of Action | X-Ray Contrast Activity |
Medical Subject Heading (MeSH) Categories for 020608
Suppliers and Packaging for NDA: 020608
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OMNIPAQUE 350 | iohexol | SOLUTION;INJECTION, ORAL | 020608 | NDA | GE Healthcare Inc. | 0407-1413 | 0407-1413-86 | 10 BOTTLE, PLASTIC in 1 BOX (0407-1413-86) / 50 mL in 1 BOTTLE, PLASTIC |
| OMNIPAQUE 350 | iohexol | SOLUTION;INJECTION, ORAL | 020608 | NDA | GE Healthcare Inc. | 0407-1413 | 0407-1413-87 | 10 BOTTLE, PLASTIC in 1 BOX (0407-1413-87) / 100 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INJECTION, ORAL, RECTAL | Strength | 51.8% | ||||
| Approval Date: | Oct 24, 1995 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION, ORAL, RECTAL | Strength | 64.7% | ||||
| Approval Date: | Oct 24, 1995 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION, ORAL | Strength | 75.5% | ||||
| Approval Date: | Oct 24, 1995 | TE: | RLD: | No | |||||
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