Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Lupin Pharmaceuticals' FYAVOLV (Norethindrone Acetate/Ethinyl Estradiol)
The FDA has approved ANDA204213 for FYAVOLV, a prescription oral tablet combining norethindrone acetate and ethinyl estradiol, manufactured by Lupin Pharmaceuticals.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Discontinues HALOPERIDOL Injectable (ANDA070802)
The FDA has marked the HALOPERIDOL injectable (product 001) as discontinued under application ANDA070802 submitted by Smith & Nephew.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA203048 for Clindamycin Phosphate Injection by Rising
The FDA granted approval for Rising’s clindamycin phosphate injection products (6, 12, and 18 mg/mL) under application ANDA203048.
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 ANDA202002: Strides Pharma Submits Original Application for IMIQUIMOD 5% Cream
Strides Pharma filed ANDA202002 for a 5% IMIQUIMOD topical cream (product 001). The original submission was listed as approved on 24‑Jun‑2014.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA201251 for Vancomycin Hydrochloride Injection
FDA approved ANDA201251 submitted by Teva Pharm USA for two vancomycin hydrochloride injectable products (500 mg and 1 g per vial), both listed as discontinued.
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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
FDA Approves ARGATROBAN Injection (ANDA091665)
The FDA has approved ANDA091665 for ARGATROBAN injection, a prescription anticoagulant submitted by PH HEALTH.
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 Approves ANDA090353 for Senores Pharms Topiramate Tablets (Discontinued)
Senores Pharms' ANDA090353 for oral Topiramate tablets (25‑200 mg) received FDA approval; all listed products are marked discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Discontinues Wellcovorin Injection (ANDA089465)
The FDA records show that the injectable product Wellcovorin, containing Leucovorin Calcium (50 mg per vial), has been marked as discontinued under ANDA089465.