Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Multiple Labeling Supplements for MirtaZAPINE (ANDA 076901)
FDA's ANDA 076901 for MirtaZAPINE includes three discontinued oral tablet strengths and a series of approved labeling supplements dating from 2005 to 2025.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Discontinues TOLECTIN Oral Tolmetin Products (NDA017628)
The FDA has marked the oral Tolmetin tablets TOLECTIN 600 mg and TOLECTIN 200 mg as discontinued, with a record of multiple manufacturing and labeling submissions from 1979 to 1993.
Regulatory Updates
Sep 11, 2026•1 min read
FDA approves KAZANO alogliptin/metformin tablets (NDA 203414)
The FDA has approved the prescription oral tablet KAZANO, containing alogliptin benzoate and metformin hydrochloride, under NDA 203414.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Risperidone Tablet ANDA077784 Submitted by Ratipharm
FDA approved ANDA077784 for multiple oral risperidone tablet strengths submitted by Ratipharm; all listed products are marked discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA209102 for Generic Baclofen Tablets
The FDA approved ANDA209102 for generic baclofen oral tablets in 5‑20 mg strengths, manufactured by TruPharma, Advagen Pharma and SOLA Pharmaceuticals.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA207613 for Midodrine Hydrochloride Tablets
FDA has approved ANDA207613, authorizing oral Midodrine Hydrochloride prescription tablets in 2.5 mg, 5 mg, and 10 mg strengths from Umasuto and Rising Pharma.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves Chartwell Molecular Lamotrigine Tablet ANDA077783
FDA has approved ANDA 077783 for oral lamotrigine tablets (25‑200 mg) submitted by Chartwell Molecular, with multiple labeling submissions cleared.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Oxford Pharm Generic Simvastatin Tablets (ANDA078735)
FDA has approved Oxford Pharm's abbreviated new drug application for generic simvastatin tablets in five strengths, all prescription oral products.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves IMPAX Labs' ACARBOSE Oral Tablets (ANDA 078441)
FDA granted approval for IMPAX Labs' ANDA 078441, authorizing prescription oral tablets of ACARBOSE in 25 mg, 50 mg, and 100 mg strengths.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves KVK TECH Betaxolol Hydrochloride Oral Tablets (ANDA078962)
The FDA has approved ANDA 078962 for Betaxolol Hydrochloride oral tablets, 10 mg and 20 mg, manufactured by KVK TECH. Both products are prescription‑only.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Multiple Simvastatin Tablet Labeling Submissions (ANDA 077752)
The FDA has approved several labeling submissions for generic oral Simvastatin tablets (5‑80 mg) under ANDA 077752, confirming their prescription status.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA 076576 for Sotalol Hydrochloride Tablets by Sun Pharm Industries
The FDA approved application ANDA076576 for oral Sotalol Hydrochloride tablets (80 mg, 120 mg, 160 mg) from Sun Pharm Industries; all listed products are marked discontinued.