Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves MK Labs SOSOL 500 mg Sulfisoxazole Oral Tablet (ANDA 080036) – Discontinued
The FDA approved ANDA 080036 for MK Labs' SOSOL oral tablet containing 500 mg sulfisoxazole. The product is listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA084231 for Methocarbamol 500 mg Oral Tablet
The FDA approved ANDA084231 for a 500 mg methocarbamol tablet submitted by Puracap Pharm; the product is currently listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA083606 for Butabarital Sodium Oral Tablet
The FDA approved ANDA083606 for an oral tablet of butabarital sodium (16.2 mg) submitted by Solvay; the product is listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Apotex CILOSTAZOL (ANDA077030)
FDA has approved Apotex's oral cilostazol tablets (50 mg and 100 mg) under ANDA 077030, adding a generic phosphodiesterase‑3 inhibitor to the market.
Regulatory Updates
Sep 3, 2026•1 min read
CARACO Receives Tentative FDA Approval for Escitalopram (ANDA078219)
CARACO's ANDA078219 for oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) has been granted tentative approval by the FDA.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA208181 for Tiagabine Tablets – Amneal
FDA granted approval for ANDA208181 covering oral tiagabine hydrochloride tablets (2 mg, 4 mg, 12 mg, 16 mg) submitted by Amneal Pharms Co.; all listed products are discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA209953 for Ranolazine Extended‑Release Tablets
The FDA has approved ANDA209953 for generic Ranolazine extended‑release tablets (500 mg and 1 g) manufactured by Ascend Laboratories and sponsored by ALKEM LABS.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA 084030 for Amosene 400 mg Meprobamate Tablet
The FDA approved ANDA 084030 for the oral tablet Amosene, a 400 mg meprobamate product submitted by FernDale Labs. The listing notes the product as discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA 088872 for Thioridazine Hydrochloride Tablet (Discontinued)
The FDA has approved ANDA 088872 for an oral tablet of thioridazine hydrochloride (200 mg) submitted by Watson Labs Teva, though the product is listed as discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA078249 for Torsemide Tablets by Aurobindo Pharma
The FDA has approved application ANDA078249 for torsemide oral tablets, manufactured by Aurobindo Pharma and Rising Pharma Holdings, covering strengths from 5 mg to 100 mg.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Apotex Sotalol Hydrochloride Tablets (ANDA 076214)
The FDA has approved Apotex’s generic sotalol hydrochloride tablets (80 mg, 120 mg, 160 mg) under ANDA 076214, with labeling updates through 2023.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA081029 for Quinidine Sulfate Tablets by Sun Pharm Industries
Sun Pharm Industries received FDA approval for an ANDA (ANDA081029) covering oral quinidine sulfate tablets (100 mg). The product is listed as discontinued, with multiple supplemental approvals for manufacturing and labeling.