Regulatorische Updates

SUN PHARM INDS LTD's ANDA076786 for oral Donepezil Hydrochloride tablets (5 mg and 10 mg) has been approved by the FDA, with both products listed as discontinued.

The FDA’s ANDA084559 filing shows PANRAY’s oral elixir THEOLIXIR, containing THEOPHYLLINE 80MG/15ML, is listed as discontinued.

FDA grants approval for DIVALPROEX SODIUM tablets (ANDA078853) by Bionpharma Inc., with oral delayed‑release 125 mg, 250 mg and 500 mg equivalents.

Bell Pharma’s oral tablet of chlorpheniramine maleate (4 mg) under ANDA083062 has been marked as discontinued.

FDA issued an approval letter for ANDA 077780 covering carvedilol oral tablets (3.125 mg, 6.25 mg, 12.5 mg, 25 mg) submitted by TARO; all listed products are marked discontinued.

The FDA has approved ANDA210245 submitted by MSN for generic pomalidomide capsules in 2 mg, 3 mg, and 4 mg strengths.

FDA approved ANDA 076383 for Apotex Inc.'s oral Nizatidine capsules (150 mg and 300 mg) on Jan 23 2003; both products are listed as discontinued.

FDA assigned ANDA084080 to TABLICAPS for an oral 12.5 mg promethazine hydrochloride tablet, now listed as discontinued.

The FDA’s NDA006920 for Lederle’s oral drug Triple Sulfas includes two discontinued formulations—a suspension and a tablet—both containing trisulfapyrimidines, sulfamerazine, and sulfamethazine.

The FDA database shows a prednisolone 5 mg oral tablet submitted under ANDA080236 by Valeant Pharmaceuticals International, currently marked as discontinued.

The FDA has approved ANDA 211928 for 250 mg oral capsules of ethosuximide, manufactured by Strides Pharma Science Limited and sponsored by ONESOURCE.

FDA's ANDA 084640 for DIPHEN oral elixir, containing diphenhydramine hydrochloride 12.5 mg/5 mL, was approved for USL Pharma with multiple manufacturing supplements; the product is now discontinued.