Shandong Xinhua Pharmaceutical Company Limited Announces on New Drug Specifications and Passing the Generics Consistency Evaluation
Specifications: 5ml:100mg. Drug Category: Prescription Drugs. Registered classification: Chemicals. Applicant: Shandong Xinhua Pharmaceutical Company Limited. Application Matter: Add 5ml:100mg Specification and Apply for Consistency of Quality and Efficacy Evaluation for Generic Drugs. Reception Number: CYHB2250052. Original drug approval number: Guoyao Zhunzi H37020712. Notification number: 2023B03333. Approval Conclusion: After review, the supplementary application of 5ml:100mg was approved for this product, and the drug approval number was issued. This product passed the consistency of quality and efficacy evaluation for generic drugs.