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FDA NDA · NDA216820

TECHNETIUM TC 99M MERTIATIDE

Sponsor: JUBILANT DRAXIMAGE

APPLICATION
NDA216820
TYPE
NDA
ORIGINAL APPROVAL
2023-01-30
LATEST ACTION
2023-01-30
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

TECHNETIUM TC 99M MERTIATIDE KIT · ReferencePrescription
TECHNETIUM TC-99M MERTIATIDE KIT N/A · POWDER · INTRAVENOUS

Approval history

2023-01-30Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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