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Drugs
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Calcium-DTPA and Zinc-DTPA Information Page
FDA approves New Drug Applications for pentetate calcium trisodium injection (Calcium-DTPA) and pentetate zinc trisodium injection (Zinc-DTPA) to treat people internally contaminated with plutonium, americium, or curium.
- FDA Press Release (issued August 11, 2004)
- Questions and Answers on Calcium-DTPA and Zinc-DTPA (revised August 11, 2004)
- Approval Letter (August 11, 2004)
- Pentetate Calcium Trisodium Injection: Labeling Approved August 11, 2004
- Pentetate Zinc Trisodium Injection: Labeling Approved August 11, 2004
- Calcium-DTPA Draft Labeling (revised August 11, 2004)
- Zinc-DTPA Draft Labeling (revised August 11, 2004)
- Federal Register Notice [HTML] [PDF]
- Guidance for Industry: Calcium DTPA and Zinc DTPA Drug Products - Submitting a New Drug Application [Word] or [PDF] (August 13, 2004)
- FDA Press Release (issued September 12, 2003)
- Drug Preparedness and Response to Bioterrorism. This CDER Web page provides links to the most current information on drug therapy and vaccines, plus advice on purchasing and taking medication.
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