Regulatory Updates

The FDA granted original approval for ANDA081189, a 25 mg oral Hydrochlorothiazide tablet from Watson Labs, with multiple labeling supplements approved through 1995. The product is now discontinued.

The FDA has approved labeling and manufacturing submissions for ISOPAQUE 280, an injectable calcium, meglumine, and metrizoic acid product, under NDA 017506.

The Korean MFDS has ordered a retailer‑initiated recall of Il Dong Pharmaceutical’s Consenvita Premium 800 tablets (batch RWC009, RWC010) because of missing labeling information and packaging errors.

The FDA has approved ANDA084306 for MYDRIACYL, a 1% tropicamide ophthalmic solution marketed by Alcon Laboratories.

FDA lists ANDA076603 for Betamethasone dipropionate 0.05% cream by Chartwell Molecular; the product is marked discontinued.

FDA records show four oral tablet products of benazepril hydrochloride and hydrochlorothiazide under ANDA077483 are discontinued, with multiple supplemental labeling approvals.

FDA records show Sandoz's alprazolam extended‑release tablets (product numbers 001‑004) are discontinued, with multiple labeling supplement approvals.

The FDA has approved an ANDA for ACETAZOLAMIDE 250 mg oral tablets, with original and multiple supplemental approvals for labeling and manufacturing from 1978 to 2016.

The FDA has approved a series of labeling and REMS submissions for the prescription oral tablet combining 7.5 mg hydrocodone bitartrate and 200 mg ibuprofen under ANDA 076604.

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.

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

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