Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA078127 for Ondansetron Oral Solution
The FDA has approved application ANDA078127 for an oral ondansetron solution (4 mg/5 mL) marketed by PAI Holdings, LLC dba PAI Pharma.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves Levetiracetam (ANDA076920)
The FDA has approved ANDA076920 for Levetiracetam tablets (250 mg, 500 mg, 750 mg) manufactured by Dr. Reddy's Laboratories and sponsored by Pharmazone.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Approval for AdaRe Pharm’s Potassium Chloride Extended‑Release Tablets (ANDA 076368)
The FDA approved ANDA 076368 for two extended‑release potassium chloride tablets (10 mEq and 20 mEq) marketed by AdaRe Pharm and manufactured by Sun Pharmaceutical.
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Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants ANDA216294 Approval for Calcitonin Salmon Injection by Amneal
The FDA has approved the ANDA216294 application for a calcitonin salmon injectable (200 IU/mL) manufactured by Amneal Pharmaceuticals.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA215856 for Furosemide Injection (10 mg/mL)
The FDA has approved ANDA215856 for a 10 mg/mL furosemide injectable, manufactured by Devatis Inc. and sponsored by Saba Ilac Sanayive.
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Regulatory Updates
Sep 18, 2026•1 min read
Ajanta Pharma’s Varenicline Tartrate Tablets Receive FDA Approval (ANDA213019)
The FDA has approved Ajanta Pharma’s oral varenicline tartrate tablets (0.5 mg and 1 mg equivalents) under ANDA213019, marking a new prescription option.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA212645 for Paroxetine Extended‑Release Tablets
The FDA has approved ANDA212645 for paroxetine extended‑release tablets (12.5 mg, 25 mg, 37.5 mg) marketed by Cadila Pharm Ltd and Modavar Pharmaceuticals.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves NexAir’s Prescription Carbon Dioxide Inhalation Product (NDA215007)
The FDA’s NDA215007 for NexAir’s carbon dioxide inhalation gas (USP) is listed with approval status AP, detailing route, dosage form, and NDC codes.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves Minocycline Hydrochloride Tablets (ANDA 065131)
The FDA approved Strides Pharma's minocycline hydrochloride oral tablets (50 mg, 75 mg, 100 mg) under ANDA 065131, confirming prescription status.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA203834 for Acyclovir Oral Tablets
The FDA has approved ANDA203834 for prescription oral acyclovir tablets (400 mg and 800 mg) manufactured by Camber Pharmaceuticals and sponsored by Hetero Labs.
Regulatory Updates
Sep 15, 2026•1 min read
FDA approves NDA 017830 for Lodosyn (carbidopa) oral tablets
The FDA granted approval for NDA 017830, authorizing the prescription oral tablet Lodosyn (carbidopa) from Bausch Health US and Oceanside Pharmaceuticals.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Bausch & Lomb OFLOXACIN Ophthalmic Solution (ANDA 076622)
The FDA granted approval for Bausch & Lomb's OFLOXACIN 0.3% ophthalmic solution (prescription) under ANDA 076622, originally approved in May 2004 with a labeling update in 2020.