Sun Pharm gets manufacturing supplement approval for tadalafil ANDA covering four tablet strengths
FDA approved a chemistry, manufacturing, and controls supplement for Sun Pharm's tadalafil ANDA on August 25, 2026.
This week's filing activity is limited to a single manufacturing update for Sun Pharm's generic tadalafil.
- Sun Pharm's tadalafil tablets under ANDA208934 received an eighth supplement approval, classified as a manufacturing (CMC) submission, with the FDA marking the submission status as approved as of August 25, 20261. The approved product line covers oral tadalafil tablets in 2.5MG, 5MG, 10MG, and 20MG strengths1.
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