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NEW MEDICINES AND DRUG DISCOVERY · FDA: DRUGS · 22 October 2026

Competitive Generic Therapy Approvals

Synopsis

Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg 3/3/2025 No N/A N/A 376 Sprycel NDA 021986 213383 Dr. Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg 8/25/2023 No N/A N/A 236 Dexamethasone ANDA 088306 217695 Apotex Corp.

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