Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA084581 for Hydralazine Tablet – IVAX Sub Teva
FDA approved ANDA084581 for a 100 mg oral tablet of Hydralazine Hydrochloride by IVAX Sub Teva Pharm on Sep 12 1975; the product is now discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA083442 for Meprobamate 400mg Oral Tablet
The FDA approved ANDA083442 for a 400 mg oral tablet of meprobamate submitted by Whiteworth Town Plsn; the product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA088262 for Imipramine Hydrochloride Tablets by Strides Pharma
The FDA has approved the ANDA for Imipramine Hydrochloride 25 mg oral tablets (brand name IMIPRAMINE HYDROCHLORIDE) manufactured by Strides Pharma Science Limited, with the latest labeling approval on May 1 2023.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Lists Fexofenadine Hydrochloride Products Under ANDA076502
The FDA database shows multiple oral tablet products of Fexofenadine Hydrochloride under application ANDA076502, with strengths from 30 mg to 180 mg, some discontinued and others OTC.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Multiple Risperidone Tablet Products under ANDA 078269
FDA has approved several oral risperidone tablet strengths ranging from 0.25 mg to 4 mg under ANDA 078269, with labeling submissions completed.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA 085767 for Phendimetrazine Tartrate 35 mg Tablet (Watson Labs)
The FDA has approved ANDA 085767 for a 35 mg oral tablet of phendimetrazine tartrate submitted by Watson Labs; the product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
KV Pharma’s Quinine Sulfate Tablet (ANDA 085276) Marked Discontinued by FDA
The FDA’s ANDA085276 for KV Pharma’s oral quinine sulfate 200 mg tablet is listed as discontinued, indicating it is no longer marketed.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA 088734 for Meclizine Hydrochloride Tablet
FDA granted approval for ANDA 088734, an oral 25 mg Meclizine Hydrochloride tablet by PLIVA. The product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
Copley Pharm’s Amitriptyline Hydrochloride Tablet (ANDA 088423) Discontinued
The FDA lists Copley Pharm’s oral Amitriptyline Hydrochloride 50 mg tablet (product #001) under ANDA 088423 as discontinued.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves Levetiracetam (ANDA076920)
The FDA has approved ANDA076920 for Levetiracetam tablets (250 mg, 500 mg, 750 mg) manufactured by Dr. Reddy's Laboratories and sponsored by Pharmazone.
Regulatory Updates
Sep 18, 2026•1 min read
Ajanta Pharma’s Varenicline Tartrate Tablets Receive FDA Approval (ANDA213019)
The FDA has approved Ajanta Pharma’s oral varenicline tartrate tablets (0.5 mg and 1 mg equivalents) under ANDA213019, marking a new prescription option.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA077824 for Ranitidine Tablets by Amneal Pharmaceuticals
The FDA has granted approval for ANDA077824, authorizing Amneal Pharmaceuticals’ oral ranitidine tablets in 150 mg and 300 mg strengths, now listed as discontinued.