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 12, 2026•1 min read
FDA Approves ANDA078902 for Paroxetine Hydrochloride Tablets
The FDA has approved ANDA078902 for generic paroxetine hydrochloride tablets (10‑40 mg) manufactured by Mylan Pharmaceuticals.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA077545 for Ondansetron Hydrochloride Tablets
FDA approved application ANDA077545 from Hikma International Pharmaceuticals for discontinued oral ondansetron tablets (4 mg, 8 mg, 24 mg) with multiple labeling supplements approved.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Teva Generic Olanzapine (ANDA 077243)
The FDA has approved Teva Pharmaceuticals’ generic olanzapine oral tablets (5‑20 mg) under ANDA 077243, with several labeling supplements filed since 2014.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Grants ANDA214126 Approval for SUGAMMADEX SODIUM Intravenous Solutions
The FDA has approved Teva Pharm USA's ANDA214126 for two intravenous SUGAMMADEX SODIUM solutions (200 mg/2 mL and 500 mg/5 mL).
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 Labeling Updates for Generic Levofloxacin Tablets (ANDA 076361)
The FDA has approved a series of labeling submissions for generic levofloxacin tablets (250 mg, 500 mg, 750 mg) under ANDA 076361, most recently on Sep 9 2024.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA204552 for Aspirin and Dipyridamole Extended-Release Capsules
FDA granted approval for ANDA204552, an oral extended‑release capsule combining 25 mg aspirin and 200 mg dipyridamole, sponsored by Chartwell Molecular.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Risperidone Tablet ANDA077784 Submitted by Ratipharm
FDA approved ANDA077784 for multiple oral risperidone tablet strengths submitted by Ratipharm; all listed products are marked discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Ohm Laboratories’ Generic Valsartan (ANDA 077492)
The FDA has granted approval for Ohm Laboratories’ generic Valsartan tablets (40‑320 mg) under application ANDA 077492.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA076609 for Propoxyphene Napyslate/Acetaminophen Tablet
The FDA approved ANDA076609 for a 100 mg propoxyphene napyslate and 650 mg acetaminophen oral tablet submitted by Watson Labs Florida; the product is listed as discontinued.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA209102 for Generic Baclofen Tablets
The FDA approved ANDA209102 for generic baclofen oral tablets in 5‑20 mg strengths, manufactured by TruPharma, Advagen Pharma and SOLA Pharmaceuticals.