Regulatory Updates
Sep 16, 2026•3 min read
FDA Approves ANDA081095 for Oral Acetaminophen/Aspirin/Codeine Capsule (Discontinued)
The FDA granted approval for labeling and manufacturing submissions for ANDA081095, a discontinued oral capsule combining acetaminophen, aspirin, and codeine phosphate, sponsored by MIKART.
Regulatory Updates
Sep 11, 2026•3 min read
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.