Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA 084553 for COMPOUND 65 Oral Capsule
FDA approved ANDA 084553 for COMPOUND 65, an oral capsule containing aspirin 389 mg, caffeine 32.4 mg, and propoxyphene HCl 65 mg; sponsor ALRA; product listed as discontinued.
Regulatory Updates
Sep 16, 2026•1 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•1 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.