Actualizaciones regulatorias
23 sept 2026•1 min de lectura
FDA Approves ANDA076667 for Fexofenadine HCl and Pseudoephedrine HCl OTC Tablet
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.
Actualizaciones regulatorias
18 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
17 sept 2026•1 min de lectura
FDA Lists Tolazamide 500 mg Oral Tablet (ANDA070169) – Discontinued
The FDA’s ANDA070169 filing for Tolazamide 500 mg oral tablets by USL Pharma is marked as discontinued.
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
FDA Approves ANDA077247 for Carboplatin Injectable Products (Discontinued)
FDA approved ANDA077247 for three carboplatin injectable products from Fresenius Kabi USA; all listed strengths are marked discontinued.
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
FDA Approves ANDA090018 for ZoleDRonic Acid Injectable (Discontinued)
Sun Pharma Global received FDA approval (ANDA090018) for a 4 mg/vial intravenous ZoleDRonic Acid injectable, currently listed as discontinued.
Actualizaciones regulatorias
8 sept 2026•1 min de lectura
FDA ANDA084259 for Methocarbamol 500 mg Oral Tablet (Mylan) – Discontinued
The FDA’s ANDA084259 for a 500 mg methocarbamol oral tablet, sponsored by Mylan, is listed as discontinued.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
FDA Approves ANDA078641 for Injectable Famotidine (Mylan)
FDA has approved ANDA078641 for a prescription injectable famotidine 10 mg/mL product marketed by Mylan Institutional LLC.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
FDA Approves ANDA084231 for Methocarbamol 500 mg Oral Tablet
The FDA approved ANDA084231 for a 500 mg methocarbamol tablet submitted by Puracap Pharm; the product is currently listed as discontinued.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
FDA Approves ANDA 086865 for Chlorpropamide Tablet (Discontinued)
The FDA granted approval (ANDA 086865) for Watson Labs' oral chlorpropamide 100 mg tablet, which is currently listed as discontinued.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
Purepac Pharm Discontinues Methocarbamol Tablet Products (ANDA085718)
FDA records show Purepac Pharm has discontinued two oral methocarbamol tablet products (500 mg and 750 mg) under ANDA 085718.