Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA080517 for Prednisolone Sodium Phosphate Injection
FDA approved an ANDA (ANDA080517) for Watson Labs' Prednisolone Sodium Phosphate injectable, originally submitted in 1974; the product is now listed as discontinued.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Labeling Updates for Discontinued Fenofibrate Tablet Products (ANDA 076520)
The FDA has approved a series of labeling submissions for three discontinued oral fenofibrate tablet products (54 mg, 107 mg, 160 mg) under ANDA 076520, with approvals spanning 2005‑2021.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Apotex Latanoprost Ophthalmic Solution (ANDA077697)
The FDA approved Apotex's ANDA077697 for a generic latanoprost ophthalmic solution, with labeling supplements approved in 2012 and 2015.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Multiple Simvastatin Tablet Labeling Submissions (ANDA 077752)
The FDA has approved several labeling submissions for generic oral Simvastatin tablets (5‑80 mg) under ANDA 077752, confirming their prescription status.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA084712 for Bethanechol Chloride Tablet (10 mg) – Lannett
The FDA has approved ANDA084712 for Bethanechol Chloride 10 mg tablets, marketed by Lannett, now listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Actavis Labs Metoprolol Succinate Extended‑Release Tablets (ANDA 076862)
Actavis Labs FL Inc received FDA approval for its metoprolol succinate extended‑release tablets under ANDA 076862, covering a prescription 50 mg product and a discontinued 25 mg product.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA078511 for Midazolam Hydrochloride Injection
FDA approved ANDA078511 submitted by PH HEALTH for two injectable Midazolam Hydrochloride products (1 mg/mL and 5 mg/mL), both listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
Cipla Efavirenz 600mg Tablet Gets FDA Tentative Approval (ANDA 077916)
Cipla Limited’s generic efavirenz 600 mg tablet has been granted tentative approval by the FDA under ANDA 077916.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Ranbaxy Ramipril Capsules (ANDA078849)
FDA approves ANDA078849 submitted by Ranbaxy Labs Ltd for oral ramipril 5 mg and 10 mg capsules, both listed as discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA077655 for VALACYCLOVIR HYDROCHLORIDE Tablets
FDA has approved ANDA077655 for valacyclovir hydrochloride oral tablets (500 mg and 1 g) from Teva Pharm, with original and supplemental labeling approvals.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Apotex Sotalol Hydrochloride Tablets (ANDA 076214)
The FDA has approved Apotex’s generic sotalol hydrochloride tablets (80 mg, 120 mg, 160 mg) under ANDA 076214, with labeling updates through 2023.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Zydus Generic Galantamine Hydrobromide Tablets (ANDA078898)
FDA has approved ANDA078898 for Zydus Pharm's oral galantamine hydrobromide tablets (4 mg, 8 mg, 12 mg) with standard labeling submissions.