Details for New Drug Application (NDA): 209166
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NDA 209166 describes SODIUM IODIDE I 131, which is a drug marketed by CIS, Curium, Jubilant, and Intl Isotopes, and is included in six NDAs. It is available from two suppliers. Additional details are available on the SODIUM IODIDE I 131 profile page.
The generic ingredient in SODIUM IODIDE I 131 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 SODIUM IODIDE I 131 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 209166
| Tradename: | SODIUM IODIDE I 131 |
| Applicant: | Intl Isotopes |
| Ingredient: | sodium iodide i-131 |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209166
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM IODIDE I 131 | sodium iodide i-131 | SOLUTION;ORAL | 209166 | ANDA | International Isotopes Inc | 69208-000 | 69208-000-00 | 1 KIT in 1 BOX (69208-000-00) * 3 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-35) * 2 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-25) * 1 CARTON in 1 BOX / 2 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK * 1 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 250-1000mCi | ||||
| Approval Date: | Feb 5, 2020 | TE: | AA | RLD: | No | ||||
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