Regulatory Updates

FDA issued an approval letter for Bedford's ANDA078114 covering ciprofloxacin injection products (200 mg/100 mL and 400 mg/200 mL), both listed as discontinued.

The FDA has approved ANDA076914 for a discontinued oral tablet combining 37.5 mg tramadol hydrochloride and 325 mg acetaminophen, submitted by Graviti Pharms.

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 Hospira's aztreonam injectable (1 g and 2 g vials) for intramuscular and intravenous use under ANDA206517.

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.

The FDA has granted approval for Sun Pharmaceutical Industries’ Zolpidem Tartrate extended‑release tablets (6.25 mg and 12.5 mg) under ANDA 204170.

FDA has approved Alkem Labs Ltd's ANDA207651 for three prescription topical creams containing triac­cinolone acetonide at 0.025%, 0.1% and 0.5% strengths.

FDA approves Sevelamer Carbonate oral suspension (ANDA207291), a prescription product available in 800 mg and 2.4 g packets, sponsored by Macleods Pharms.