Received ANDA Approval for Droxidopa Capsules, 100 mg, 200 mg, and 300 mg
Received ANDA Approval for Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg
Received ANDA Approval for Levetiracetam Extended-Release Tablets USP, 500 mg and 750 mg.
Received ANDA Tentative Approval for Pirfenidone Tablets, 267 mg and 801 mg
Received ANDA Tentative Approval for Pirfenidone Capsules, 267 mg
Received ANDA Approval for Ezetimibe Tablets, 10mg
Received ANDA Tentative Approval for Lacosamide Tablets, 50 mg, 100 mg, 150 mg, and 200 mg
Sciegen Metformin product – not part of Recall<br><br> Sciegen Pharmaceuticals Inc states that the Immediate release tablets Metformin Hydrochloride Tablets, USP 500 mg, 850 mg & 1000 mg manufactured by Sciegen Pharmaceuticals Inc are not part of recall regarding Metformin products.<br><br> Sciegen Metformin IR tablets complying to FDA requirements of NDMA content less 96 nanograms (0.0376 ppm).<br><br> Several batches manufactured by Sciegen are tested with a validated test method and the levels are found to ‘below detectable limit’.<br><br> This data has been submitted to FDA.
Received ANDA Approval for Naproxen Tablets USP 250mg, 375mg and 500mg