Details for New Drug Application (NDA): 216016
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NDA 216016 describes IOMERVU, 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 IOMERVU profile page.
The generic ingredient in IOMERVU is iomeprol. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iomeprol profile page.
The generic ingredient in IOMERVU is iomeprol. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iomeprol profile page.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216016
Generic Entry Date for 216016*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
SOLUTION;INTRA-ARTERIAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 216016
| Mechanism of Action | X-Ray Contrast Activity |
Suppliers and Packaging for NDA: 216016
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IOMERVU | iomeprol | SOLUTION;INTRA-ARTERIAL | 216016 | NDA | BRACCO DIAGNOSTICS INC | 0270-7017 | 0270-7017-21 | 10 BOTTLE, GLASS in 1 CASE (0270-7017-21) / 100 mL in 1 BOTTLE, GLASS |
| IOMERVU | iomeprol | SOLUTION;INTRA-ARTERIAL | 216016 | NDA | BRACCO DIAGNOSTICS INC | 0270-7017 | 0270-7017-25 | 10 BOTTLE, GLASS in 1 CASE (0270-7017-25) / 200 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRA-ARTERIAL | Strength | 25GM IODINE/100ML (250MG IODINE/ML) | ||||
| Approval Date: | Nov 27, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 27, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRA-ARTERIAL | Strength | 15GM IODINE/50ML (300MG IODINE/ML) | ||||
| Approval Date: | Nov 27, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 27, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRA-ARTERIAL | Strength | 30GM IODINE/100ML (300MG IODINE/ML) | ||||
| Approval Date: | Nov 27, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 27, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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