The U.S. Food and Drug Administration has approved the Abbreviated New Drug Application (ANDA) 077222 for fosinopril sodium tablets.
The approval covers oral tablets in three strengths – 10 mg, 20 mg, and 40 mg – each listed under product numbers 001, 002, and 003 respectively. All are prescription‑only human drugs.
The sponsor listed is Invagen Pharms. The original application (submission 1) received approval on 20 April 2005. Subsequent labeling supplements (submissions 5 and 7) were approved on 26 January 2016.
Manufacturer names appearing in the FDA data include Cipla USA Inc. and Exelan Pharmaceuticals, Inc. The tablets are identified by multiple NDC codes (e.g., 69097‑856‑05, 76282‑200‑10).
規制動向2026年9月18日•3分で読めます
FDA Approves ANDA077222 for Fosinopril Sodium Tablets
The FDA has approved ANDA077222 for generic fosinopril sodium oral tablets in 10 mg, 20 mg, and 40 mg strengths, sponsored by Invagen Pharms.
Pharmacountryチームがまとめました · 出典： FDA.gov
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