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Generated: April 30, 2017

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Details for New Drug Application (NDA): 203137

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NDA 203137 describes VIZAMYL, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the VIZAMYL profile page.

The generic ingredient in VIZAMYL is flutemetamol f-18. One supplier is listed for this compound. Additional details are available on the flutemetamol f-18 profile page.

Summary for NDA: 203137


Pharmacology for NDA: 203137

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 203137

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
flutemetamol f-18
INJECTABLE;INTRAVENOUS 203137 NDA Medi-Physics Inc. 17156-067 17156-067-10 1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-10) > 10 mL in 1 VIAL, MULTI-DOSE
flutemetamol f-18
INJECTABLE;INTRAVENOUS 203137 NDA Medi-Physics Inc. 17156-067 17156-067-30 1 VIAL, MULTI-DOSE in 1 CONTAINER (17156-067-30) > 30 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength40.5mCi/10ML (4.05mCi/ML)
Approval Date:Oct 25, 2013TE:RLD:Yes
Patent:8,236,282Patent Expiration:May 21, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:8,916,131Patent Expiration:Sep 16, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:7,270,800Patent Expiration:Sep 3, 2025Product Flag?YSubstance Flag?YDelist Request?

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