Regulatory UpdatesAug 31, 2026•1 min read

FDA Approves Ranbaxy Ramipril Capsules (ANDA078849)

By the PharmaCountry team

FDA approves ANDA078849 submitted by Ranbaxy Labs Ltd for oral ramipril 5 mg and 10 mg capsules, both listed as discontinued.

The U.S. Food and Drug Administration (FDA) has issued an approval (status “AP”) for ANDA078849, an abbreviated new drug application submitted by Ranbaxy Labs Ltd. The application covers two oral ramipril capsule products – 5 mg (product number 001) and 10 mg (product number 002). Both are listed with a marketing status of “Discontinued.” The original submission was filed on 2009‑03‑06.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#ramipril #ANDA #FDA #generic #Capsule #discontinued