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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Resources for You

Approval History, Letters, Reviews, and Related Documents - Rotarix

Proper Name: Rotavirus Vaccine, Live, Oral
Tradename: Rotarix
Manufacturer: GlaxoSmithKline Biologicals, License #1617
STN: 125265/0
Approval Date: April 3, 2008

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Memorandum/Reviews

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Administrative Documents

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Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448