Regulatory Updates
Sep 22, 2026•1 min read
FDA Approves Ethosuximide Oral Syrup (ANDA 081306)
The FDA has approved the oral syrup formulation of ethosuximide (250 mg/5 ml) under ANDA 081306, with multiple manufacturing and labeling submissions listed.
Regulatory Updates
Sep 17, 2026•1 min read
FDA NDA012126: 3M's ULO Oral Syrup Discontinued
The FDA records show that 3M's oral syrup product ULO, containing 25 mg/5 mL chlophedianol hydrochloride, is listed as discontinued under application NDA012126.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves NDA011960 for ARISTOCORT Oral Syrup (Triamcinolone Acetate)
The FDA approved NDA011960 for ARISTOCORT oral syrup, a 2 mg/5 mL Triamcinolone Acetate product by Astellas, now listed as discontinued.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA 077105 for Valproic Acid Oral Syrup
FDA has approved multiple labeling supplements for the discontinued VALPROIC ACID oral syrup (ANDA 077105). Original approval dates to 2005.
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.
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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Regulatory Updates
Aug 30, 2026•1 min read
FDA Discontinues Piperazine Citrate Syrup (ANDA080774)
The FDA has listed the oral syrup product Piperazine Citrate (product 001) from Alpharma US Pharms as discontinued under ANDA080774.
Regulatory Updates
Aug 25, 2026•1 min read
FDA Updates Labeling for Discontinued Oral Syrup DEPAKENE (Valproic Acid)
The FDA record for NDA018082 lists DEPAKENE syrup as discontinued, with a Federal Register note that safety was not a factor, and details multiple labeling submissions from 1981 to 2016.