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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 two suppliers. 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. Three suppliers are listed for this compound. Additional details are available on the technetium tc-99m pyrophosphate kit profile page.

Summary for NDA: 017538

Pharmacology for NDA: 017538

Mechanism of ActionRadiopharmaceutical Activity

Suppliers and Packaging for NDA: 017538

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
technetium tc-99m pyrophosphate kit
INJECTABLE;INJECTION 017538 NDA Mallinckrodt Inc. 0019-9094 0019-9094-20 5 VIAL in 1 CELLO PACK (0019-9094-20) > 10 mL in 1 VIAL
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

Summary 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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