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Generated: November 18, 2018

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Details for New Drug Application (NDA): 017538

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NDA 017538 describes TECHNESCAN PYP KIT, which is a drug marketed by Mallinkrodt Nuclear and is included in one NDA. It is available from one supplier. Additional details are available on the TECHNESCAN PYP KIT profile page.

The generic ingredient in TECHNESCAN PYP KIT is technetium tc-99m pyrophosphate kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m pyrophosphate kit profile page.
Summary for 017538
Suppliers and Packaging for NDA: 017538
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TECHNESCAN PYP KIT technetium tc-99m pyrophosphate kit INJECTABLE;INJECTION 017538 NDA MALLINCKRODT NUCLEAR MEDICINE LLC 69945-094 69945-094-20 5 VIAL in 1 CELLO PACK (69945-094-20) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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