The FDA announced approval of ANDA077824 for ranitidine tablets submitted by Amneal Pharmaceuticals of New York LLC.
The approved products are oral tablets containing ranitidine hydrochloride, available in 150 mg and 300 mg base‑equivalent strengths. Both are listed with marketing status "Discontinued."
Submission history includes an original submission approved on 13 Oct 2006, supplemental labeling approval on 30 Oct 2010, and manufacturing (CMC) approvals on 20 Mar 2008 and 7 Feb 2017.
The products are identified under NDC codes 53746‑253‑* and 53746‑254‑* and are classified as human prescription drugs.
規制動向2026年9月17日•3分で読めます
FDA Approves ANDA077824 for Ranitidine Tablets by Amneal Pharmaceuticals
The FDA has granted approval for ANDA077824, authorizing Amneal Pharmaceuticals’ oral ranitidine tablets in 150 mg and 300 mg strengths, now listed as discontinued.
Pharmacountryチームがまとめました · 出典： FDA.gov
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