法规动态

FDA、EMA、TGA 及全球法规动态

#Levetiracetam ×

2026年9月18日•1 分钟阅读

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.

2026年9月17日•1 分钟阅读

FDA Approves Mylan Generic Levetiracetam Tablets (ANDA 076919)

The FDA has approved Mylan Pharmaceuticals' generic levetiracetam tablets (250 mg, 500 mg, 750 mg) under ANDA 076919.

2026年9月9日•1 分钟阅读

FDA Approves Lupin Generic Levetiracetam Tablets (ANDA 078154)

The FDA has approved Lupin Pharmaceuticals’ generic levetiracetam tablets in 250 mg, 500 mg, and 750 mg oral strengths under ANDA 078154.

2026年9月4日•1 分钟阅读

FDA Approves Multiple Labeling Updates for Levetiracetam Oral Solution

The FDA has approved several labeling supplement submissions for the discontinued oral solution Levetiracetam (100 mg/mL) spanning from 2011 to 2024.

2026年8月30日•1 分钟阅读

FDA Approves Levetiracetam Oral Solution (ANDA078976)

FDA has approved ANDA078976 for Levetiracetam oral solution, a prescription drug manufactured by Actavis Pharma, Inc., with a detailed submission history.

2026年8月28日•1 分钟阅读

FDA Approves Generic Levetiracetam Tablets (ANDA078993)

The FDA has approved labeling for generic levetiracetam tablets, 250 mg to 1 g, from BluePoint Laboratories and Aurobindo Pharma.

2026年8月26日•1 分钟阅读

FDA Approves ANDA078101 for Teva’s Levetiracetam Oral Tablets

The FDA has approved labeling submissions for Teva Pharm’s discontinued levetiracetam tablets (250 mg, 500 mg, 750 mg, 1 g) under ANDA078101.