Regulatory UpdatesSep 3, 2026•1 min read

FDA Approves ANDA078511 for Midazolam Hydrochloride Injection

By the PharmaCountry team

FDA approved ANDA078511 submitted by PH HEALTH for two injectable Midazolam Hydrochloride products (1 mg/mL and 5 mg/mL), both listed as discontinued.

The U.S. Food and Drug Administration (FDA) has granted approval (status AP) for application ANDA078511 submitted by PH HEALTH. The original submission (submission number 1) was approved on 2008-11-10. The approval covers two injectable products of Midazolam Hydrochloride: - Product 001: injectable, 1 mg/mL (EQ 1MG BASE/ML), marketing status discontinued. - Product 002: injectable, 5 mg/mL (EQ 5MG BASE/ML), marketing status discontinued. Both products are classified as injections, are not reference drugs, and do not have a reference standard. The sponsor listed is PH HEALTH.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#midazolam #injection #ANDA #FDA #pharmaceuticals #generic