Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#hydralazine ×
Actualizaciones regulatorias
28 sept 2026•1 min de lectura
FDA Approves ANDA 084469 for Hydralazine Hydrochloride 50 mg Tablet (IVAX Sub Teva Pharm)
The FDA granted approval for ANDA 084469, covering a 50 mg oral tablet of hydralazine hydrochloride submitted by IVAX Sub Teva Pharm. The product is listed as discontinued.
Actualizaciones regulatorias
19 sept 2026•1 min de lectura
FDA Approves ANDA084581 for Hydralazine Tablet – IVAX Sub Teva
FDA approved ANDA084581 for a 100 mg oral tablet of Hydralazine Hydrochloride by IVAX Sub Teva Pharm on Sep 12 1975; the product is now discontinued.
Actualizaciones regulatorias
8 sept 2026•1 min de lectura
FDA Approves ANDA086088 for Hydralazine Hydrochloride Oral Tablet (Discontinued)
The FDA has listed ANDA086088 for Hydralazine Hydrochloride 25 mg oral tablets submitted by Vitarine, noting the product is discontinued.
Actualizaciones regulatorias
5 sept 2026•1 min de lectura
FDA Approves Sandoz DRALSERP Tablet (Hydralazine HCl/Reserpine) – ANDA084617
The FDA approved Sandoz's ANDA084617 for the oral tablet DRALSERP containing hydralazine hydrochloride 25 mg and reserpine 0.1 mg; the product is listed as discontinued.
Actualizaciones regulatorias
26 ago 2026•1 min de lectura
FDA Approves Multiple Submissions for APRESAZIDE (ANDA 084735)
The FDA lists APRESAZIDE oral capsules (hydralazine HCl 25 mg / hydrochlorothiazide 25 mg) as discontinued, with a series of approved original and supplemental submissions from 1976 to 1998.