General MedicationsINJECTIONStandard
HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE
Standard Dose
20MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview HYDRALAZINE HYDROCHLORIDE is listed in Drugs@FDA under application 219797 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient HYDRALAZINE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - 20MG/ML Sponsor BAXTER HLTHCARE CORP Submission history Latest submission status date: 2025-07-17 00:00:00.
Structured Monograph
Clinical summary
Approval overview HYDRALAZINE HYDROCHLORIDE is listed in Drugs@FDA under application 219797 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient HYDRALAZINE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - 20MG/ML Sponsor BAXTER HLTHCARE CORP Submission history Latest submission status date: 2025-07-17 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.