Regulatorische Updates

The FDA has approved ANDA085790 for an oral 100 mg Isoniazid tablet submitted by Watson Labs. The product is currently listed as discontinued.

The FDA has approved the injectable drug FLUMAZENIL (application ANDA076955) from Fresenius Kabi USA, available in two IV strengths.

The FDA’s ANDA084259 for a 500 mg methocarbamol oral tablet, sponsored by Mylan, is listed as discontinued.

FDA has approved ANDA078654 submitted by SUN PHARM INDS INC for clonazepam orally disintegrating tablets across several strengths; all listed products are currently discontinued.

The FDA has approved ANDA078889 for generic metoprolol succinate extended‑release tablets (100 mg and 200 mg) from several manufacturers.

The FDA has listed Hydroxyzine Hydrochloride injectable (product 001) from sponsor Smith and Nephew as discontinued under ANDA087592.

The FDA has marked the oral tablet product Dextroamphetamine Sulfate (5 mg) from sponsor MAST MM as discontinued under ANDA 086521.

The FDA approved ANDA085964 for Sandoz's oral tablet containing 300 mg acetaminophen and 60 mg codeine phosphate; the product is listed as discontinued after multiple labeling submissions.

The FDA has approved ANDA 076251 submitted by Barr for fluoxetine hydrochloride oral capsules, 40 mg base, now listed as discontinued.

FDA has approved Apotex's oral cilostazol tablets (50 mg and 100 mg) under ANDA 077030, adding a generic phosphodiesterase‑3 inhibitor to the market.

The FDA has approved ANDA209953 for generic Ranolazine extended‑release tablets (500 mg and 1 g) manufactured by Ascend Laboratories and sponsored by ALKEM LABS.

The FDA approved ANDA 084030 for the oral tablet Amosene, a 400 mg meprobamate product submitted by FernDale Labs. The listing notes the product as discontinued.