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 8, 2026•1 min read
FDA Approves SUN PHARM INDS INC ANDA078654 for Clonazepam ODTs
FDA has approved ANDA078654 submitted by SUN PHARM INDS INC for clonazepam orally disintegrating tablets across several strengths; all listed products are currently discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Labeling Updates for Chartwell Rx’s Discontinued Desloratadine Tablet (ANDA078364)
The FDA has granted several labeling approvals for Chartwell Rx’s desloratadine 5 mg oral tablet (ANDA078364), though the product is listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves CALCITRIOL Injection (ANDA078066)
FDA granted approval for CALCITRIOL injectable products (ANDA078066) from LONG GROVE PHARMS, including a prescription 0.001 mg/mL product and a discontinued 0.002 mg/mL version.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA077766 for Simvastatin Generic Tablets
The FDA granted approval for Chartwell Rx's ANDA077766, covering five discontinued Simvastatin tablet strengths and subsequent labeling updates.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA076589 for FLUMAZENIL Injectable Products
FDA approved ANDA076589 submitted by Dr Reddys, covering two injectable FLUMAZENIL products, both listed with discontinued marketing status.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA077165 for Granisetron Hydrochloride Preservative‑Free Injection (DR REDDYS)
The FDA approved ANDA077165 for a preservative‑free granisetron hydrochloride injectable product by Dr. Reddys; the product is listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Sandoz ANDA076873 for Metformin Hydrochloride Extended‑Release Tablet
The FDA has approved Sandoz's ANDA076873 for a prescription oral metformin hydrochloride 500 mg extended‑release tablet, with multiple labeling supplements approved.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA083022 for DODEX Injectable (Cyanocobalamin)
The FDA approved ANDA083022 for the DODEX injectable containing 1 mg/mL cyanocobalamin. The product is listed as discontinued.
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Regulatory Updates
Sep 8, 2026•1 min read
FDA Discontinues Isoniazid Oral Tablet (ANDA083632)
The FDA has listed the 50 mg oral tablet Isoniazid, marketed by Halsey, as discontinued under application ANDA083632.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA080693 for Hydrocortisone 1% Topical Cream
The FDA has approved application ANDA080693 for a prescription 1% hydrocortisone topical cream marketed as HYDROCORTISONE by Fougera Pharm Inc.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Discontinues ANDA 080086 for Triple Sulfa Oral Tablet by Purepac Pharm
The FDA has listed the ANDA 080086 submission for the oral tablet Triple Sulfa, containing trisulfapyrimidines, sulfamerazine, and sulfamethazine, as discontinued.