規制動向
2026年9月27日•1分で読めます
FDA Approves ANDA077302 for Actavis Extended‑Release Amphetamine Combination Capsules
The FDA approved ANDA077302 for Actavis Pharma’s oral extended‑release capsules containing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate in multiple strengths.
規制動向
2026年9月11日•1分で読めます
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.
規制動向
2026年8月27日•1分で読めます
FDA Announces Discontinued Alprazolam Extended‑Release Tablets (ANDA 077198)
The FDA’s ANDA 077198 for alprazolam extended‑release tablets submitted by Actavis Labs FL Inc shows all listed products as discontinued.