01 3Bracco
02 1CIS bio international
03 3Cisbio
04 114GE Healthcare Inc
05 4IBA molecular
06 1ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.
07 1International Isotopes
08 4Jubilant DraxImage Inc
09 6Jubilant Generics
10 2MAP Medical Technologies Oy
11 1Mallinckrodt Pharmaceuticals
12 55NTP Radioisotopes Soc Ltd
01 55CAP
02 2CAPSULE
03 9CAPSULE;ORAL
04 110Capsule
05 5HARD CAPSULES
06 1ORAL LIQUID
07 3SOLUTION
08 2SOLUTION FOR INJECTION
09 8SOLUTION;ORAL
01 14DISCN
02 55Originator
03 3RX
04 5Schedule C
05 118Blank
01 1Capsion
02 1DRAXIMAGE SODIUM IODIDE I131 CAPSULES, USP DIAGNOSTIC
03 1DRAXIMAGE SODIUM IODIDE I131 CAPSULES, USP THERAPEUTIC
04 1DRAXIMAGE SODIUM IODIDE I131 SOLUTION, USP DIAGNOSTIC
05 1DRAXIMAGE SODIUM IODIDE I131 SOLUTION, USP THERAPEUTIC
06 4HICON
07 3IODOTOPE
08 1SODIUM IODIDE (131I) SOLUTION
09 10SODIUM IODIDE I 131
10 4Sodium Iodide I-131 Diag Caps
11 51Sodium Iodide I-131 Ther Caps
12 3Sodium iodide (I-131) GE Healthcare
13 2Sodium iodide (I-131) MAP
14 1Sodium iodide (I-131) Mallinckrodt Medical
15 1Theracap
16 110Theracap 131TM
01 5Canada
02 110Norway
03 55South Africa
04 8Sweden
05 17USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : IODOTOPE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1-130mCi
Packaging :
Approval Date : 1982-01-01
Application Number : 10929
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : IODOTOPE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 7-106mCi/BOT
Packaging :
Approval Date : 1982-01-01
Application Number : 10929
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : IODOTOPE
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1-150mCi
Packaging :
Approval Date : 1982-01-01
Application Number : 10929
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM IODIDE I 131
Dosage Form : SOLUTION;ORAL
Dosage Strength : 50mCi/ML
Packaging :
Approval Date : 1982-01-01
Application Number : 17315
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM IODIDE I 131
Dosage Form : CAPSULE;ORAL
Dosage Strength : 50uCi
Packaging :
Approval Date : 1982-01-01
Application Number : 17316
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM IODIDE I 131
Dosage Form : CAPSULE;ORAL
Dosage Strength : 100uCi
Packaging :
Approval Date : 1982-01-01
Application Number : 17316
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Sodium iodide (I-131) GE Healthcare
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 925 MBQ / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Sodium iodide (I-131) GE Healthcare
Dosage Form : HARD CAPSULES
Dosage Strength : 333-3700 KBQ
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM IODIDE I 131
Dosage Form : SOLUTION;ORAL
Dosage Strength : 3.5-150mCi/VIAL
Packaging :
Approval Date : 1982-01-01
Application Number : 16515
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM IODIDE I 131
Dosage Form : CAPSULE;ORAL
Dosage Strength : 0.8-100mCi
Packaging :
Approval Date : 1982-01-01
Application Number : 16515
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM IODIDE I 131
Dosage Form : CAPSULE;ORAL
Dosage Strength : 0.8-100mCi
Packaging :
Approval Date : 1982-01-01
Application Number : 16517
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM IODIDE I 131
Dosage Form : CAPSULE;ORAL
Dosage Strength : 15-100uCi
Packaging :
Approval Date : 1982-01-01
Application Number : 16517
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM IODIDE I 131
Dosage Form : SOLUTION;ORAL
Dosage Strength : 250-1000mCi
Packaging :
Approval Date : 2020-02-05
Application Number : 209166
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : HICON
Dosage Form : SOLUTION;ORAL
Dosage Strength : 1-250mCi/0.25ML
Packaging :
Approval Date : 2003-01-24
Application Number : 21305
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : HICON
Dosage Form : SOLUTION;ORAL
Dosage Strength : 1-500mCi/0.5ML
Packaging :
Approval Date : 2003-01-24
Application Number : 21305
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : SODIUM IODIDE I 131
Dosage Form : CAPSULE;ORAL
Dosage Strength : 2-200mCi
Packaging :
Approval Date : 2004-11-18
Application Number : 21305
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : HICON
Dosage Form : SOLUTION;ORAL
Dosage Strength : 1-1000mCi/ML
Packaging :
Approval Date : 2006-04-04
Application Number : 21305
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SODIUM IODIDE I 131
Dosage Form : CAPSULE;ORAL
Dosage Strength : 0.009-0.1mCi
Packaging :
Approval Date : 2005-05-19
Application Number : 21305
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : HICON
Dosage Form : SOLUTION;ORAL
Dosage Strength : 250-1000mCi
Packaging :
Approval Date : 2011-12-05
Application Number : 21305
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Capsion
Dosage Form : HARD CAPSULES
Dosage Strength : 50-3700 MBQ
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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