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Product Information
Registration Number BR-664
Generic Name Cholera Vaccine (inactivated, oral)
Brand Name OraVacs
Dosage Strength Formulation Each capsule contains: Inactivated Whole Cell (WC)-5.0 x 10^10 of Vibrio cholerae 01 Inaba, classical biotype (heat inactivated) Recombinant cholera toxin B subunit (ICTB)--1 mg (produced in V. cholerae 01 Inaba, classical biotype or El Tor biotype)
Dosage Form Enteric-Coated Capsule
Classification Prescription Drug (RX)
Packaging Aluminum blister foil (Box of 3's)
Pharmacologic Category Vaccines
Manufacturer Shanghai United Cell Biotechnology Co., Ltd.
Country of Origin China
Trader
Importer ULIVaccines, Inc.
Distributor GB Distributors Inc.
Application Type Renewal
Issuance Date 31 May 2024
Expiry Date 26 November 2029