Regulatorische Updates

The FDA has approved application ANDA076330 for octreotide acetate injectable products manufactured by Hikma Pharmaceuticals, available in two dosage strengths.

FDA has approved ANDA076885 for Rabeprazole Sodium oral delayed‑release tablets (20 mg) sponsored by Pharmobedient, with multiple labeling submissions approved between 2013 and 2023.

FDA has approved Hikma's Granisetron Hydrochloride injectable (ANDA077177) with labeling updates in 2014 and 2022, confirming its prescription status.

The FDA approved Mylan's ANDA077486 for GLIMEPIRIDE tablets (1mg, 2mg, 4mg), though all listed products are marked as discontinued.

FDA approved ANDA077779 for metoprolol succinate extended‑release tablets from NESHER PHARMS; product listed as discontinued.

FDA has approved ANDA083666 submitted by Watson Labs for an oral tablet combining 50 mg hydrochlorothiazide and 0.125 mg reserpine; the product is listed as discontinued.

The FDA has approved several supplemental labeling and manufacturing submissions for the oral capsule product Procaineamide Hydrochloride, which is currently listed as discontinued.

The FDA approved ANDA 084744 on Dec 9 1975 for Meprobamate tablets (200 mg and 400 mg) marketed by Parke Davis, now listed as discontinued.

FDA approved multiple labeling submissions for Teva's granisetron hydrochloride oral tablet (ANDA078080), which is listed as discontinued.

The FDA approved labeling submissions for the oral tablet containing norethindrone 0.4 mg and ethinyl estradiol 0.035 mg (ANDA078379) submitted by Watson Labs.

FDA granted approval for ANDA078671 covering prescription NABUMETONE tablets (500 mg and 750 mg) from sponsor Invagen Pharms, manufactured by Exelan Pharmaceuticals and Cipla USA.

The FDA approved ANDA080126 on Jan 21 1972 for Everylife's STANOZIDE oral tablets containing 100 mg and 300 mg of isoniazid, both now listed as discontinued.