Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves Teva Methylphenidate Hydrochloride ER Capsules (ANDA 077707)
FDA has approved Teva Pharm’s methylphenidate hydrochloride extended‑release capsules in 10 mg, 20 mg and 30 mg strengths under ANDA 077707.
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 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 8, 2026•1 min read
FDA Approves Labeling for Teva’s Discontinued Ramipril Capsules (ANDA 077470)
Teva Pharmaceuticals’ oral ramipril capsule products (1.25‑10 mg) were listed as discontinued, with multiple FDA labeling supplements approved between 2008 and 2014.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA 088872 for Thioridazine Hydrochloride Tablet (Discontinued)
The FDA has approved ANDA 088872 for an oral tablet of thioridazine hydrochloride (200 mg) submitted by Watson Labs Teva, though the product is listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Teva Hydrochlorothiazide 50 mg Tablet (ANDA 088923)
The FDA approved Teva’s ANDA 088923 for a 50 mg oral hydrochlorothiazide tablet; the product is listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Teva Generic Carvedilol Tablets (ANDA 076373)
The FDA has granted approval for Teva Pharmaceuticals' generic carvedilol oral tablets, covering strengths from 3.125 mg to 25 mg under ANDA 076373.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Grants Approval for Teva’s Chlordiazepoxide Hydrochloride (ANDA 084768)
The FDA has approved Teva Pharmaceuticals’ oral capsule generic of chlordiazepoxide hydrochloride under ANDA 084768, with multiple supplemental manufacturing and labeling approvals.
Regulatory Updates
Aug 30, 2026•1 min read
FDA approves ANDA 078079 for ciclopirox 8% topical solution
FDA issued an approval letter on Sep 25, 2007 for Teva Pharms' ANDA 078079 covering a discontinued ciclopirox 8% topical solution.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Labeling for Granisetron Hydrochloride Tablet (ANDA078080)
FDA approved multiple labeling submissions for Teva's granisetron hydrochloride oral tablet (ANDA078080), which is listed as discontinued.
Regulatory Updates
Aug 26, 2026•1 min read
FDA Approves Teva Torsemide Generic Tablets (ANDA 076346)
The FDA has approved Teva Pharmaceuticals’ ANDA 076346 for torsemide oral tablets in 5 mg, 10 mg, 20 mg and 100 mg strengths, prescription‑only.