Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA063264 for Amikacin Sulfate Injection
The FDA approved ANDA063264 for Amikacin Sulfate injectable by Hospira. The product is listed as discontinued and includes multiple labeling and manufacturing supplemental submissions.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA071510 for Clorazepate Dipotassium Oral Capsule
The FDA has approved ANDA071510 for a 7.5 mg oral capsule of clorazepate dipotassium, with the product now listed as discontinued and several labeling supplements approved.
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 17, 2026•1 min read
FDA Approves Multiple Manufacturing and Labeling Submissions for Discontinued Ibuprofen Tablet
The FDA has approved a series of supplemental applications covering manufacturing and labeling for a discontinued 200 mg oral ibuprofen tablet (product 001).
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Zydus Pharms Indomethacin Extended‑Release Capsule (ANDA202711)
FDA has approved ANDA202711 for Zydus Pharms' prescription indomethacin 75 mg extended‑release oral capsule, with labeling supplements filed in 2017, 2019, 2021 and 2024.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Records Submissions for Teva’s Discontinued Amlodipine/Valsartan/HCTZ Tablets (ANDA 200435)
FDA records multiple labeling submissions for Teva’s discontinued oral tablet combining amlodipine besylate, valsartan, and hydrochlorothiazide (ANDA 200435). All listed product variants are marked discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Submissions for CALAN Verapamil Tablets (NDA 018817)
The FDA record for NDA 018817 lists multiple labeling and manufacturing submissions for CALAN verapamil tablets, all currently marked as discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
Recall: Platinum Naturals Easymulti Stress (Men) Vitamin B6 Mislabel
Health Canada has recalled Platinum Naturals Easymulti Stress (Men) capsules (lots 737‑737C) due to incorrect Vitamin B6 labeling. Retailers should remove affected products.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Multiple Submissions for Indomethacin NDA 018858, Products Discontinued
The FDA has approved a series of manufacturing and labeling submissions for Indomethacin (NDA 018858). Both listed capsule products (25 mg and 50 mg) are marked discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Records Show Discontinued BENEMID (Probenecid) Tablet with Multiple Priority Submissions
The FDA database lists BENEMID, an oral 500 mg probenecid tablet, as discontinued but not for safety or effectiveness reasons, and documents numerous priority supplemental submissions spanning 1976‑1994.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Multiple Manufacturing and Labeling Submissions for SLO‑BID (Theophylline 50 mg)
The FDA has approved a series of manufacturing (CMC) and labeling submissions for SLO‑BID, an oral extended‑release theophylline capsule, now listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Sun Pharm ANDA077373 for Octreotide Acetate Injectable Products
FDA granted approval for Sun Pharm's ANDA077373 covering two discontinued octreotide acetate injectable products, with labeling updates approved in 2013 and 2017.