Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Multiple Clozapine Submissions; All Listed Tablet Products Discontinued
FDA records show four discontinued oral tablet strengths of Clozapine and several approved REMS and labeling submissions spanning 2015‑2025.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Ohm Laboratories’ Generic Valsartan (ANDA 077492)
The FDA has granted approval for Ohm Laboratories’ generic Valsartan tablets (40‑320 mg) under application ANDA 077492.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Chartwell RX Levofloxacin Oral Tablets (ANDA 076890)
The FDA has granted approval for Chartwell RX’s levofloxacin tablets in 250 mg, 500 mg and 750 mg oral strengths under ANDA 076890.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA076336 for MirtaZAPINE Oral Tablets
The FDA has approved application ANDA076336 for MirtaZAPINE oral tablets in 15 mg, 30 mg, and 45 mg strengths, submitted by Actavis Labs FL Inc.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA208756 for Dexmethylphenidate Tablets (Rhodes Pharm)
The FDA has approved application ANDA208756 submitted by Rhodes Pharm for oral dexmethylphenidate hydrochloride tablets in 2.5 mg, 5 mg and 10 mg strengths, though the products are listed as discontinued.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves Sevelamer Hydrochloride Generic (ANDA 206883) by Macleods Pharmaceuticals
The FDA has approved the generic drug Sevelamer Hydrochloride (ANDA 206883) from Macleods Pharmaceuticals, available as 400 mg and 800 mg oral tablets.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Discontinues Oral Prednisolone Tablet (ANDA083675)
The FDA has listed the oral prednisolone 5 mg tablet (product 001) from sponsor Bundy as discontinued under ANDA083675.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA078384 for Carvedilol Tablets by Unichem Pharmaceuticals
The FDA has approved ANDA078384 for carvedilol oral tablets (3.125‑25 mg) manufactured by Unichem Pharmaceuticals and sponsored by Regcon Holdings.
Regulatory Updates
Sep 10, 2026•1 min read
MEPROBAMATE (ANDA 085721) Discontinued Oral Tablet – FDA
FDA records show the oral tablet MEPROBAMATE (400 mg) is discontinued, with multiple manufacturing and labeling submissions approved between 1983 and 1999.
Regulatory Updates
Sep 10, 2026•1 min read
FDA ANDA084751 Approval for DILOR-400 (400 mg Theophylline)
DILOR-400, an oral tablet containing 400 mg theophylline, was approved under ANDA084751 with multiple manufacturing supplements; the product is currently discontinued.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA 084286 for Triamcinolone 2mg Oral Tablet – Discontinued
The FDA approved ANDA 084286 submitted by BARR for a 2 mg oral tablet of Triamcinolone. The product is listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
CAM-METRAZINE (ANDA085320) Discontinued Oral Tablet by Chartwell Rx
Chartwell Rx’s oral tablet CAM-METRAZINE, containing 35 mg phendimetrazine tartrate, is listed as discontinued. The FDA ANDA record shows multiple manufacturing and labeling submissions.