Regulatory Updates

NESHER PHARMS received FDA approval (submission AP) for ANDA076640 covering Metoprolol Succinate extended‑release tablets (200 mg and 100 mg equivalents), though both products are listed as discontinued.

The FDA has approved a series of labeling submissions for generic levofloxacin tablets (250 mg, 500 mg, 750 mg) under ANDA 076361, most recently on Sep 9 2024.

FDA has approved the ANDA206097 application for Zydus Pharm's prescription LINEZOLID 600 mg oral tablet, with labeling approvals up to July 2026.

The FDA issued a standard review tentative approval (TA) for ANDA205757 submitted by Pharmascience Inc., status dated Feb 15, 2019.

FDA records indicate CAPLIN's paricalcitol intravenous solutions (product numbers 001‑003) are discontinued, with original ANDA204910 approved in 2016 and labeling updates in 2024.

FDA granted approval for ANDA204552, an oral extended‑release capsule combining 25 mg aspirin and 200 mg dipyridamole, sponsored by Chartwell Molecular.

FDA records show four discontinued oral tablet strengths of Clozapine and several approved REMS and labeling submissions spanning 2015‑2025.

The FDA has approved the prescription oral tablet KAZANO, containing alogliptin benzoate and metformin hydrochloride, under NDA 203414.

CYLERT, an oral chewable tablet with 37.5 mg PEMOLINE, is listed as discontinued. The FDA record shows a series of labeling, manufacturing and priority submissions from 1976 to 2005.

FDA granted approval for Hikma's deferoxamine mesylate injectable products (ANDA078086), available in 500 mg and 2 g vials, both listed as discontinued.

FDA approved ANDA077784 for multiple oral risperidone tablet strengths submitted by Ratipharm; all listed products are marked discontinued.

The FDA has approved application ANDA076336 for MirtaZAPINE oral tablets in 15 mg, 30 mg, and 45 mg strengths, submitted by Actavis Labs FL Inc.