| 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)
|
| Pharmacologic Category |
Vaccines
|
| Packaging |
Aluminum blister foil (Box of 3's)
|
| 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
|