Shandong Xinhua Pharmaceutical Company Limited received the Notice of Approval of Supplementary Drug Application issued by the National Medical Products Administration in relation to the approval of Dobutamine Hydrochloride Injection which has passed the "Consistency of Quality and Efficacy Evaluation for Generic Drugs". Relevant information is now announced as follows: Drug Name: Dobutamine Hydrochloride Injection. Dosage form: Injection
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.