The FDA has approved application ANDA204552 for the generic product "Aspirin and Dipyridamole" marketed as an oral extended‑release capsule.
The capsule contains 25 mg aspirin and 200 mg dipyridamole per unit, is administered orally, and is listed with a marketing status of discontinued.
Sponsor Chartwell Molecular submitted three filings: an original submission (submission number 1) dated 20 Mar 2019, and two supplemental labeling submissions (numbers 2 and 5) both approved on 29 Aug 2023.
All submissions were reviewed under a standard priority.
Regulatorische Updates11. Sept. 2026•3 Min. Lesezeit
FDA Approves ANDA204552 for Aspirin and Dipyridamole Extended-Release Capsules
FDA granted approval for ANDA204552, an oral extended‑release capsule combining 25 mg aspirin and 200 mg dipyridamole, sponsored by Chartwell Molecular.
Zusammengestellt vom Pharmacountry-Team · Quelle: FDA.gov
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