General MedicationsINTRAVENOUSGeneric

LABETALOL HYDROCHLORIDE

Standard Dose

10MG/2ML (5MG/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: N/A Marketing status: Discontinued

Summary

Approval overview LABETALOL HYDROCHLORIDE is listed in Drugs@FDA under application 213330 (NDA).

Review priority: N/A Marketing status: Discontinued Active ingredient LABETALOL HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 10MG/2ML (5MG/ML) Sponsor HIKMA Submission history Latest submission status date: 2024-08-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview LABETALOL HYDROCHLORIDE is listed in Drugs@FDA under application 213330 (NDA). Review priority: N/A Marketing status: Discontinued Active ingredient LABETALOL HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 10MG/2ML (5MG/ML) Sponsor HIKMA Submission history Latest submission status date: 2024-08-19 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: N/A

Interaction Notes

No interaction notes stored yet.