Regulatory Updates
Sep 28, 2026•1 min read
FDA Discontinues Lactulose Oral/Rectal Solution (NDA017906)
The FDA has listed the Lactulose oral and rectal solution (product #001) as discontinued under NDA017906, sponsored by Solvay.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Discontinues Duraquin (Quinine Gluconate) – NDA017917
FDA records show Warner Chilcott's Duraquin oral extended‑release tablet (quinine gluconate 330 mg) is discontinued under application NDA017917.
Regulatory Updates
Sep 23, 2026•1 min read
FDA Approves Multiple Supplemental Applications for LIDOPEN (NDA 017549)
The FDA has granted approval for several supplemental submissions related to LIDOPEN, an injectable lidocaine product now discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA NDA006920: Lederle's Triple Sulfas Oral Products Listed as Discontinued
The FDA’s NDA006920 for Lederle’s oral drug Triple Sulfas includes two discontinued formulations—a suspension and a tablet—both containing trisulfapyrimidines, sulfamerazine, and sulfamethazine.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Priority Approval to EPIZYME’s Orphan Drug TAZVERIK (TAZEMETOSTAT HYDROBROMIDE 200 mg)
The FDA approved TAZVERIK, a prescription oral tablet for EPIZYME Inc., under NDA 213400 with priority review and orphan designation.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Sanofi Aventis NDA012283 for HYGROTON Chlorthalidone Tablets
The FDA has granted approval (NDA012283) for Sanofi Aventis’s HYGROTON oral tablets containing chlorthalidone 25 mg and 50 mg, previously listed as discontinued but not withdrawn for safety reasons.
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 17, 2026•1 min read
FDA NDA050306: Discontinued GEOPEN Injectable Carbenicillin Products
The FDA record NDA050306 lists five GEOPEN injectable carbenicillin products, all marked discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA approves NDA 017830 for Lodosyn (carbidopa) oral tablets
The FDA granted approval for NDA 017830, authorizing the prescription oral tablet Lodosyn (carbidopa) from Bausch Health US and Oceanside Pharmaceuticals.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves NDA017421 for DIAL Topical Solution Containing 0.25% Hexachlorophene
The FDA granted approval (NDA017421) for DIAL’s discontinued topical solution containing 0.25% hexachlorophene.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Assigns NDA 214937 for Helium Inhalation Product by Westair Gases
The FDA has listed NDA 214937 for a prescription helium inhalation gas (HELIUM, USP) submitted by Westair Gases & Equipment Inc., with submission documents dated June‑July 2020.