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FDA, EMA, TGA and global regulatory developments

#Ranitidine ×

UPDATED
Regulatory Updates
Sep 17, 2026•1 min read
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.
UPDATED
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Ranitidine Oral Syrup (ANDA077405)
The FDA has granted approval for ANDA077405, an oral Ranitidine hydrochloride syrup (15 mg/ml) manufactured by Pharmaceutical Associates, Inc., with labeling updates through 2010.
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