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Generated: November 17, 2018

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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 seven 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:MEGATOPE
Applicant:Iso Tex
Ingredient:albumin iodinated i-131 serum
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)

Profile for product number 001

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

Profile for product number 002

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

Profile 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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