Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Multiple Labeling Supplements for MirtaZAPINE (ANDA 076901)
FDA's ANDA 076901 for MirtaZAPINE includes three discontinued oral tablet strengths and a series of approved labeling supplements dating from 2005 to 2025.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA076336 for MirtaZAPINE Oral Tablets
The FDA has approved application ANDA076336 for MirtaZAPINE oral tablets in 15 mg, 30 mg, and 45 mg strengths, submitted by Actavis Labs FL Inc.
Regulatory Updates
Aug 23, 2026•1 min read
Cadila Pharmaceuticals reports barcode error on Mirtazapine 30mg tablets
Cadila Pharmaceuticals notified the MHRA of an incorrect EAN barcode on cartons of a batch of Mirtazapine 30mg film-coated tablets distributed by Crescent Pharma.