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3/17/2008 Telecon 1 - Rotarix

Communication - Telecon

Printed Date: March 17

Appl Type: BLA       STN: L 125265/0.0

Subm Type: Original Application     Lic #: 1617

Status: Filed     Status Date:02-AUG-2007

Applicant: GlaxoSmithKline Biologicals

Author Henchal, Laraine S

Date/Time: 17-MAR-2008
Originated By: 13:55:00 FDA

Send to DCC Date:
Outside Phone#: 610-787-3767

Communication Categories: Information Request

Related STNs:

Related PMCs:

Summary: Requested timeline for post-market study


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002