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FDA、EMA、TGA および世界の規制動向

#hydroxyzine ×

UPDATED
規制動向
2026年9月28日•1分で読めます
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.
UPDATED
規制動向
2026年9月23日•1分で読めます
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 086822)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor SoloPak as discontinued under ANDA 086822.
UPDATED
規制動向
2026年9月16日•1分で読めます
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA 089107)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor PharmaFair as discontinued under ANDA 089107.
UPDATED
規制動向
2026年9月8日•1分で読めます
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.
UPDATED
規制動向
2026年9月5日•1分で読めます
FDA Discontinues Hydroxyzine Hydrochloride Injection (ANDA087592)
The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor Smith and Nephew as discontinued under ANDA087592.
UPDATED
規制動向
2026年8月25日•1分で読めます
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.