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FDA, EMA, TGA and global regulatory developments

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UPDATED
Regulatory Updates
Sep 19, 2026•1 min read
FDA Issues ANDA084080 for Promethazine Hydrochloride Tablet
FDA assigned ANDA084080 to TABLICAPS for an oral 12.5 mg promethazine hydrochloride tablet, now listed as discontinued.
UPDATED
Regulatory Updates
Sep 8, 2026•1 min read
CENCI Announces Discontinuation of PROMETHAZINE Oral Syrup (ANDA089013)
CENCI's PROMETHAZINE oral syrup (product 001) is listed as discontinued in the FDA ANDA089013 filing.