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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016515

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NDA 016515 describes SODIUM IODIDE I 131, which is a drug marketed by Jubilant Draximage, Mallinkrodt Nuclear, and CIS, and is included in five 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 three hundred and ninety-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 NDA: 016515

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 016515

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 016515

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM IODIDE I 131
sodium iodide i-131
CAPSULE;ORAL 016515 NDA MALLINCKRODT NUCLEAR MEDICINE LLC 69945-450 69945-450-01 1 VIAL in 1 CAN (69945-450-01) > 1 mL in 1 VIAL
SODIUM IODIDE I 131
sodium iodide i-131
CAPSULE;ORAL 016515 NDA MALLINCKRODT NUCLEAR MEDICINE LLC 69945-450 69945-450-02 1 VIAL in 1 CAN (69945-450-02) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength3.5-150mCi/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength0.8-100mCi
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Deloitte
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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