Product Approval Information - Licensing Action
Proper name: Rotavirus Vaccine, Live, Oral, Tetravalent
Tradename: RotaShield
Manufacturer: Wyeth Laboratories, Inc, Marietta, PA, License #0003
Indication for Use: Immunization of infants at 2, 4, and 6 months of age
Approval Date: 8/31/98
Type of submission: Biologics license application
Approval Letter -
(PDF),
(Text)
Label - (PDF)
HHS News
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