Regulatory UpdatesSep 19, 2026•1 min read

FDA Approves ANDA084581 for Hydralazine Tablet – IVAX Sub Teva

By the PharmaCountry team

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.

The U.S. Food and Drug Administration (FDA) issued an approval for ANDA 084581 on September 12, 1975. The application covers an oral tablet formulation of Hydralazine Hydrochloride at a strength of 100 mg. The product, listed under the brand name HYDRALAZINE HYDROCHLORIDE, is manufactured by IVAX SUB TEVA PHARMS. It is classified as a generic (reference drug: No) and was submitted as an original (ORIG) application, submission number 1. According to the FDA record, the marketing status of the product is "Discontinued," indicating that while the ANDA was approved, the tablet is no longer marketed.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#hydralazine #ANDA #FDA #Oral Tablet #generic drug #approval