규제 업데이트

The FDA approved ANDA076667 for an over‑the‑counter extended‑release oral tablet containing 60 mg fexofenadine HCl and 120 mg pseudoephedrine HCl, marketed by Dr. Reddy’s.

The FDA has approved ANDA215856 for a 10 mg/mL furosemide injectable, manufactured by Devatis Inc. and sponsored by Saba Ilac Sanayive.

The FDA’s ANDA070169 filing for Tolazamide 500 mg oral tablets by USL Pharma is marked as discontinued.

FDA approved ANDA077247 for three carboplatin injectable products from Fresenius Kabi USA; all listed strengths are marked discontinued.

Sun Pharma Global received FDA approval (ANDA090018) for a 4 mg/vial intravenous ZoleDRonic Acid injectable, currently listed as discontinued.

The FDA’s ANDA084259 for a 500 mg methocarbamol oral tablet, sponsored by Mylan, is listed as discontinued.

FDA has approved ANDA078641 for a prescription injectable famotidine 10 mg/mL product marketed by Mylan Institutional LLC.

The FDA has approved several labeling submissions for generic oral Simvastatin tablets (5‑80 mg) under ANDA 077752, confirming their prescription status.

The FDA approved ANDA084231 for a 500 mg methocarbamol tablet submitted by Puracap Pharm; the product is currently listed as discontinued.

The FDA granted approval (ANDA 086865) for Watson Labs' oral chlorpropamide 100 mg tablet, which is currently listed as discontinued.

FDA records show Purepac Pharm has discontinued two oral methocarbamol tablet products (500 mg and 750 mg) under ANDA 085718.