FDA Approves Hydroxyzine Hydrochloride Injection (ANDA 088184)

The U.S. Food and Drug Administration has approved ANDA 088184 for Hydroxyzine Hydrochloride injection. The product, marketed by Fresenius Kabi USA, is administered via injection, has an injectable dosage form, product number 001, and contains 25 mg/mL of Hydroxyzine Hydrochloride. It is listed as a reference drug "No" and its marketing status is "Discontinued". Fresenius Kabi USA submitted a series of applications for this product. The original ANDA (submission 1) was approved on 31 Mar 1983. Subsequent manufacturing (CMC) supplements (submissions 2, 3, 4, and 6) received approval on 3 Aug 1988, 5 Oct 1990, 5 Oct 1990, and 21 May 2007 respectively. A labeling supplement (submission 5) was approved on 29 May 1991. Additionally, a safety labeling change order letter (ID 53924) was issued on 1 May 2018 and is available on the FDA website. The approval documentation includes details on the product’s route (INJECTION), dosage form, active ingredient strength, and the sponsor’s submission history, providing a comprehensive regulatory record for this discontinued injectable product.