Regulatory Updates
Sep 28, 2026•1 min read
FDA Approves Hydroxyzine Hydrochloride Injection (ANDA 088184)
FDA approves ANDA 088184 for Hydroxyzine Hydrochloride injectable product by Fresenius Kabi USA, with multiple labeling and manufacturing submissions.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 086822)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor SoloPak as discontinued under ANDA 086822.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 089107)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor PharmaFair as discontinued under ANDA 089107.
Regulatory Updates
Sep 8, 2026•1 min read
Hydroxyzine Hydrochloride 50 mg Tablet Discontinued – FDA Submission History
FDA records indicate the oral Hydroxyzine Hydrochloride 50 mg tablet (product 001) is discontinued, with multiple manufacturing and labeling submissions approved between 1989 and 2016.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA087592)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor Smith and Nephew as discontinued under ANDA087592.
Regulatory Updates
Aug 25, 2026•1 min read
FDA Approves ANDA087274 for Hydroxyzine Injectable – Watson Labs
FDA approved ANDA087274 for two hydroxyzine hydrochloride injectable products from Watson Labs; both are now listed as discontinued.