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.
Actualizaciones regulatorias31 ago 2026•1 min de lectura
FDA Approves Ranbaxy Ramipril Capsules (ANDA078849)
FDA approves ANDA078849 submitted by Ranbaxy Labs Ltd for oral ramipril 5 mg and 10 mg capsules, both listed as discontinued.
Recopilado por el equipo de PharmaCountry · Fuente: FDA.gov
Calificaciones
(0)
(0)
(0)
(0)
(0)
Más artículos
Ver todos los artículosInvestigación e Informes
Global Finished Dosage Manufacturing Landscape 2026
5 oct 2026
Actualizaciones regulatoriasKorea Korus hit with 1‑month manufacturing suspension over missing post‑marketing safety test
28 sept 2026
AnálisisPharma distributors set delivery cut‑offs ahead of Chuseok holiday (Sep 21‑23)
28 sept 2026
Deja tu valoración