Regulatory Updates
Sep 28, 2026•1 min read
FDA Approves ANDA 084469 for Hydralazine Hydrochloride 50 mg Tablet (IVAX Sub Teva Pharm)
The FDA granted approval for ANDA 084469, covering a 50 mg oral tablet of hydralazine hydrochloride submitted by IVAX Sub Teva Pharm. The product is listed as discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Glenmark’s Carvedilol Generic Tablets (ANDA078251)
The FDA has granted labeling approval for Glenmark Pharmaceuticals’ generic carvedilol tablets (ANDA078251), available in 3.125 mg, 6.25 mg, 12.5 mg and 25 mg oral dosage forms.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA077222 for Fosinopril Sodium Tablets
The FDA has approved ANDA077222 for generic fosinopril sodium oral tablets in 10 mg, 20 mg, and 40 mg strengths, sponsored by Invagen Pharms.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves Carvedilol Generic (ANDA 076649) by Dr. Reddy's Laboratories
FDA granted approval for ANDA 076649, a carvedilol oral tablet generic from Dr. Reddy's Laboratories, covering four strengths and prescription use.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Zydus Verapamil Hydrochloride Injection (ANDA214215)
FDA has approved ANDA214215 for Zydus' injectable verapamil hydrochloride (2.5 mg/mL), a prescription IV product for cardiovascular use.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Oxford Generic Amlodipine Besylate Tablets (ANDA078414)
FDA granted approval for ANDA078414, authorizing Oxford Pharmaceuticals' generic amlodipine besylate tablets in 2.5 mg, 5 mg, and 10 mg strengths.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves Reserpine and Hydroflumethiazide Tablet (ANDA 088932)
The FDA granted approval (AP) for ANDA 088932 submitted by IVAX PHARMS for an oral tablet containing 0.125 mg reserpine and 50 mg hydroflumethiazide; the product is listed as discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
Teva Pharm’s Simvastatin Tablet ANDA 076532 Receives Tentative FDA Approval
The FDA granted tentative approval to Teva Pharm’s generic simvastatin tablets (5‑80 mg) under ANDA 076532.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves NESHER PHARMS Metoprolol Succinate Extended‑Release ANDA076640
NESHER PHARMS received FDA approval (submission AP) for ANDA076640 covering Metoprolol Succinate extended‑release tablets (200 mg and 100 mg equivalents), though both products are listed as discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA077183 for Amlodipine Besylate and Benazepril Hydrochloride
The FDA has granted approval for ANDA077183, a prescription oral capsule combining amlodipine besylate and benazepril hydrochloride, manufactured by Dr. Reddy's Laboratories.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves CARDIZEM CD (Diltiazem Hydrochloride) Extended‑Release Capsules
The FDA has approved CARDIZEM CD, an extended‑release oral capsule of diltiazem hydrochloride (NDA020062), manufactured by Bausch Health US LLC.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Grants Approval for Metoprolol Tartrate Injectable (ANDA078085) by Hospira
The FDA has approved Hospira’s Metoprolol Tartrate injectable (ANDA078085), an intravenous prescription drug with a 1 mg/mL strength.