規制動向

FDA、EMA、TGA および世界の規制動向

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2026年9月28日•1分で読めます

FDA Discontinues Hydrocortisone 0.5% Ointment (ANDA084969)

The FDA has listed the hydrocortisone 0.5% topical ointment (product 003) from Perrigo New York as discontinued under application ANDA084969.

2026年9月25日•1分で読めます

FDA Approves ANDA078547 for Nicotine Polacrilex OTC Chewing Gum

The FDA has approved ANDA078547 for a 2 mg nicotine polacrilex chewing gum, an over‑the‑counter nicotine replacement product marketed under several brand names.

2026年8月30日•1分で読めます

FDA ANDA083061: Diphenhydramine Hydrochloride Capsules Discontinued

FDA ANDA083061 lists two oral diphenhydramine hydrochloride capsule products (25 mg and 50 mg) from Perrigo, both marked discontinued.