Regulatory Updates
Sep 17, 2026•1 min read
FDA Lists Tolazamide 500 mg Oral Tablet (ANDA070169) – Discontinued
The FDA’s ANDA070169 filing for Tolazamide 500 mg oral tablets by USL Pharma is marked as discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Registers Manufacturing Submissions for Discontinued Ibuprofen Tablet (ANDA 071144)
The FDA’s ANDA 071144 records show a discontinued ibuprofen 200 mg oral tablet and a series of approved manufacturing (CMC) and labeling submissions spanning 1987‑1997.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA203834 for Acyclovir Oral Tablets
The FDA has approved ANDA203834 for prescription oral acyclovir tablets (400 mg and 800 mg) manufactured by Camber Pharmaceuticals and sponsored by Hetero Labs.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Methyclothiazide Tablet (ANDA 088750)
The FDA has approved ANDA 088750 for a 2.5 mg oral tablet of methyclothiazide submitted by Watson Labs; the product is listed as discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA 088119 for Isoniazid 300 mg Tablet
The FDA approved application ANDA088119 for an oral Isoniazid 300 mg tablet marketed by Duramed Pharms Barr. The product is listed as discontinued and includes a detailed submission history.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Lannett’s VELTANE 4 mg Oral Tablet (ANDA 084088)
The FDA has granted approval for Lannett’s generic VELTANE oral tablet containing 4 mg brompheniramine maleate (ANDA 084088).
Regulatory Updates
Sep 16, 2026•1 min read
FDA Lists ANDA080493 for Purepac CORTISONE ACETATE Oral Tablet (Discontinued)
The FDA entry ANDA080493 shows Purepac Pharm's oral CORTISONE ACETATE 25 mg tablet is listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Discontinues Diphynoxylate Hydrochloride/Atropine Sulfate Tablet (ANDA 087934)
FDA records show ASCOT's oral tablet containing diphenoxylate hydrochloride 2.5 mg and atropine sulfate 0.025 mg is listed as discontinued under ANDA 087934.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA087564 for Isosorbide Dinitrate Tablet
The FDA approved application ANDA087564 for Sun Pharm Industries' oral tablet Isosorbide Dinitrate 30 mg, listed with a discontinued marketing status.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Grants Labeling Approval for Olmesartan Medoxomil Tablets (ANDA 078276)
FDA has approved labeling for oral Olmesartan Medoxomil tablets (5 mg, 20 mg, 40 mg) under ANDA 078276 submitted by Rising; the products are listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Lists ANDA083706 for Mylan Propantheline Bromide 15 mg Tablet
FDA records an ANDA (ANDA083706) for Mylan's oral propantheline bromide 15 mg tablet, currently marked as 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.