法规动态
2026年9月23日•1 分钟阅读
Roche’s ENDEP (Amitriptyline HCl 150mg) ANDA085303 Approved; product now discontinued
The FDA approved Roche’s ANDA085303 for ENDEP, an oral 150 mg amitriptyline hydrochloride tablet. The product is currently listed as discontinued.
法规动态
2026年9月12日•1 分钟阅读
FDA Approves NIPRIDE (Sodium Nitroprusside) Injection – NDA 017546
FDA approved Roche's injectable NIPRIDE (sodium nitroprusside 50 mg/vial) under NDA 017546 in 1974; the product is now discontinued after multiple labeling updates.
法规动态
2026年9月6日•1 分钟阅读
Roche and Eli Lilly's Elecsys pTau217 Blood Test Receives FDA Approval
Roche and Eli Lilly's Elecsys pTau217 blood test for Alzheimer’s received FDA clearance, measuring phosphorylated tau 217 to aid diagnosis and exclusion.
法规动态
2026年8月25日•1 分钟阅读
FDA Lists ENDEP Amitriptyline Tablet Products (ANDA083639)
FDA’s ANDA083639 lists five ENDEP oral amitriptyline tablets (10‑100 mg) from Roche, all marked discontinued.