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Regulatory Updates

FDA, EMA, TGA and global regulatory developments

#Levetiracetam ×

UPDATED
Regulatory Updates
Sep 18, 2026•1 min read
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.
UPDATED
Regulatory Updates
Sep 17, 2026•1 min read
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.
UPDATED
Regulatory Updates
Sep 9, 2026•1 min read
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.
UPDATED
Regulatory Updates
Sep 4, 2026•1 min read
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.
UPDATED
Regulatory Updates
Aug 30, 2026•1 min read
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.
UPDATED
Regulatory Updates
Aug 28, 2026•1 min read
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.
UPDATED
Regulatory Updates
Aug 26, 2026•1 min read
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.