Details for New Drug Application (NDA): 010929
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NDA 010929 describes IODOTOPE, which is a drug marketed by Bracco and is included in one NDA. Additional details are available on the IODOTOPE profile page.
The generic ingredient in IODOTOPE 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.
The generic ingredient in IODOTOPE 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 010929
| Tradename: | IODOTOPE |
| Applicant: | Bracco |
| Ingredient: | sodium iodide i-131 |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 1-130mCi | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 7-106mCi/BOT | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 1-150mCi | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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