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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017837

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NDA 017837 describes MEGATOPE, which is a drug marketed by Iso Tex and is included in one NDA. It is available from one supplier. Additional details are available on the MEGATOPE profile page.

The generic ingredient in MEGATOPE is albumin iodinated i-131 serum. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the albumin iodinated i-131 serum profile page.

Summary for 017837

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

Pharmacology for NDA: 017837

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 017837

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEGATOPE albumin iodinated i-131 serum INJECTABLE;INJECTION 017837 NDA Iso-Tex Diagnostics, Inc. 50914-7720 50914-7720-8 1 mL in 1 SYRINGE, PLASTIC (50914-7720-8)
MEGATOPE albumin iodinated i-131 serum INJECTABLE;INJECTION 017837 NDA Iso-Tex Diagnostics, Inc. 50914-7731 50914-7731-4 8 mL in 1 VIAL, MULTI-DOSE (50914-7731-4)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5mCi/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1mCi/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2mCi/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Serving leading biopharmaceutical companies globally:

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Dow
Queensland Health

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