FDA Approves ANDA207613 for Midodrine Hydrochloride Tablets

The U.S. Food and Drug Administration (FDA) has granted approval for application number ANDA207613, covering Midodrine Hydrochloride tablets intended for oral administration. The approved products are prescription‑only tablets available in three strengths: 2.5 mg, 5 mg, and 10 mg. Two manufacturers are listed on the approval: Umasuto, LLC and Rising Pharma Holdings, Inc. Each product is classified as a human prescription drug and is not a reference listed drug. The original submission (type ORIG) received a standard review priority and achieved an approved status (AP) on November 2, 2018. The approved labeling includes the following product identifiers: NDC codes 85293‑005‑01, 85293‑006‑01, 85293‑007‑01, 64980‑433‑01, 64980‑434‑01, and 64980‑435‑01, corresponding to the three tablet strengths. This approval adds Midodrine Hydrochloride to the FDA’s roster of orally administered prescription therapies.