Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077652 for Levofloxacin Oral Tablets
The FDA has approved ANDA077652 for levofloxacin tablets (250 mg, 500 mg, 750 mg) manufactured by Zydus Lifesciences and Viona Pharmaceuticals.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077345 for Sertraline Hydrochloride Tablets (Heritage Pharma Avet)
The FDA has approved ANDA077345 submitted by Heritage Pharma Avet for oral sertraline hydrochloride tablets in 25 mg, 50 mg and 100 mg strengths. All listed products are currently marked discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Mometasone Furoate Topical Ointment (ANDA076481)
FDA granted approval for ANDA076481, a prescription 0.1% mometasone furoate topical ointment manufactured by Encube Ethicals, Inc.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA 088734 for Meclizine Hydrochloride Tablet
FDA granted approval for ANDA 088734, an oral 25 mg Meclizine Hydrochloride tablet by PLIVA. The product is listed as discontinued.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA078416 for Prednisolone Sodium Phosphate Oral Solution
The FDA granted approval (status AP) for Vintage Pharms' ANDA078416 covering an oral solution of prednisolone sodium phosphate on Oct 31 2007; the product is listed as discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA 076648 for Nitrofurantoin Oral Capsules (Monohydrate/Macrocrystals)
The FDA granted approval for ANDA 076648, covering nitrofurantoin (75 mg + 25 mg macrocrystalline) oral capsules marketed by Chartwell Rx.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Griseofulvin Oral Suspension (ANDA 065394)
The FDA has approved an oral suspension of griseofulvin (125 mg/5 mL) from Actavis Pharma under ANDA 065394.
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Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Sanofi Aventis NDA012283 for HYGROTON Chlorthalidone Tablets
The FDA has granted approval (NDA012283) for Sanofi Aventis’s HYGROTON oral tablets containing chlorthalidone 25 mg and 50 mg, previously listed as discontinued but not withdrawn for safety reasons.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves Methyclothiazide Tablet (ANDA 088750)
The FDA has approved ANDA 088750 for a 2.5 mg oral tablet of methyclothiazide submitted by Watson Labs; the product is listed as discontinued.
Regulatory Updates
Sep 16, 2026•1 min read
MFDS Identifies GCP Gaps in Dayvigofilm Coating Tablet (Rembolexant) Approval Process
The Korean MFDS flagged protocol adherence, monitoring and record‑keeping issues in the clinical trial for Dayvigofilm coating tablet, though no serious violations were found.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA 088119 for Isoniazid 300 mg Tablet
The FDA approved application ANDA088119 for an oral Isoniazid 300 mg tablet marketed by Duramed Pharms Barr. The product is listed as discontinued and includes a detailed submission history.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA077078 for Metformin Hydrochloride Extended‑Release Tablets
The FDA has approved the ANDA077078 application for metformin hydrochloride 750 mg extended‑release tablets marketed by Zydus Lifesciences.