Details for New Drug Application (NDA): 021305
✉ Email this page to a colleague
The generic ingredient in HICON is sodium iodide i-131. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium iodide i-131 profile page.
Summary for 021305
| Tradename: | HICON |
| Applicant: | Jubilant |
| Ingredient: | sodium iodide i-131 |
| Patents: | 0 |
Pharmacology for NDA: 021305
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 021305
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM IODIDE I 131 | sodium iodide i-131 | CAPSULE;ORAL | 021305 | NDA | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-461 | 65174-461-05 | 5 CAPSULE in 1 VIAL (65174-461-05) |
| HICON | sodium iodide i-131 | SOLUTION;ORAL | 021305 | NDA | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-461 | 65174-461-05 | 5 CAPSULE in 1 VIAL (65174-461-05) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 1-250mCi/0.25ML | ||||
| Approval Date: | Jan 24, 2003 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 1-500mCi/0.5ML | ||||
| Approval Date: | Jan 24, 2003 | TE: | RLD: | No | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 2-200mCi | ||||
| Approval Date: | Nov 18, 2004 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
