The U.S. Food and Drug Administration has granted approval for the Abbreviated New Drug Application (ANDA) 076811 for ANAGRELIDE, a prescription oral capsule.
The approval includes two capsule strengths—0.5 mg and 1 mg base equivalent—marketed under the brand name ANAGRELIDE HYDROCHLORIDE. These products are manufactured by ANI Pharmaceuticals, Inc.
Novitum Pharma is listed as the sponsor. The original application received approval on 18 April 2005, and subsequent labeling supplements were approved on 31 August 2010 (submission 5), 13 February 2013 (submission 7), and 13 November 2016 (submission 8).
ANAGRELIDE is classified as a human prescription drug, administered orally. It is identified by UNII YTM763Y5C8, RxCUI 597850/597852, and NDC codes 70954‑879‑10 and 70954‑881‑10.
規制動向2026年8月30日•1分で読めます
FDA Approves ANAGRELIDE (ANDA076811)
FDA has approved the generic oral capsule ANAGRELIDE under ANDA076811, covering 0.5 mg and 1 mg strengths, sponsored by Novitum Pharma and manufactured by ANI Pharmaceuticals.
PharmaCountryチームがまとめました · 出典： FDA.gov
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