Details for New Drug Application (NDA): 018956
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The generic ingredient in OMNIPAQUE 70 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 018956
Tradename: | OMNIPAQUE 70 |
Applicant: | Ge Healthcare |
Ingredient: | iohexol |
Patents: | 0 |
Pharmacology for NDA: 018956
Mechanism of Action | X-Ray Contrast Activity |
Medical Subject Heading (MeSH) Categories for 018956
Suppliers and Packaging for NDA: 018956
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OMNIPAQUE 140 | iohexol | INJECTABLE;INJECTION | 018956 | NDA | GE Healthcare Inc. | 0407-1401 | 0407-1401-52 | 10 BOTTLE, PLASTIC in 1 BOX (0407-1401-52) / 50 mL in 1 BOTTLE, PLASTIC |
OMNIPAQUE 140 | iohexol | INJECTABLE;INJECTION | 018956 | NDA | GE Healthcare Inc. | 0407-1411 | 0407-1411-10 | 10 VIAL, GLASS in 1 BOX (0407-1411-10) / 10 mL in 1 VIAL, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION, ORAL, RECTAL | Strength | 38.8% | ||||
Approval Date: | Dec 26, 1985 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION, ORAL, RECTAL | Strength | 51.8% | ||||
Approval Date: | Dec 26, 1985 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION, ORAL, RECTAL | Strength | 64.7% | ||||
Approval Date: | Dec 26, 1985 | TE: | RLD: | Yes |
Expired US Patents for NDA 018956
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ge Healthcare | OMNIPAQUE 70 | iohexol | SOLUTION;URETHRAL | 018956-007 | Jun 1, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | OMNIPAQUE 300 | iohexol | SOLUTION;INJECTION, ORAL, RECTAL | 018956-003 | Dec 26, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | OMNIPAQUE 240 | iohexol | SOLUTION;INJECTION, ORAL, RECTAL | 018956-002 | Dec 26, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | OMNIPAQUE 140 | iohexol | INJECTABLE;INJECTION | 018956-005 | Nov 30, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Ge Healthcare | OMNIPAQUE 350 | iohexol | SOLUTION;INJECTION, ORAL | 018956-004 | Dec 26, 1985 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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