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Calcium-DTPA and Zinc-DTPA
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.
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FDA Press Release (issued August 11, 2004)
- Questions and Answers on Calcium-DTPA and
Zinc-DTPA (revised August 11, 2004)
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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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Date created: September 12, 2003; Last updated: August 12, 2004 |
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