Actualizaciones regulatorias

The FDA has approved ANDA087463 for the oral tablet Oxycet, containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen, manufactured by SpecGx LLC.

FDA grants approval for Torrent Pharmaceuticals' Zolpidem Tartrate oral tablets (5 mg and 10 mg) under ANDA077903, confirming prescription status and labeling updates.

The FDA has approved labeling for Chartwell RX's fluticasone propionate nasal spray (ANDA078492), a prescription nasal spray.

The FDA has approved application ANDA077370 for generic glimepiride tablets (1‑8 mg) manufactured by Solco Healthcare U.S., LLC and sponsored by Prinston Inc.

FDA grants approval for ANDA077676, a prescription ciclopirox olamine 0.77% topical suspension from Padagis Israel Pharmaceuticals.

The FDA has granted approval for ANDA077060, authorizing the prescription extended‑release metformin hydrochloride tablet (500 mg) marketed by Zydus Lifesciences.

The FDA has approved ANDA 084282 for Dexamethasone Sodium Phosphate injectable, a prescription drug manufactured by Hikma and Civica with multiple NDC listings.

The FDA has approved application ANDA208867 for 50 mg oral tablets of propylthiouracil, manufactured by Macleods Pharmaceuticals. The labeling submission was approved on June 26 2024.

The FDA has approved preservative‑free lidocaine hydrochloride injectable products (2% and 4%) under NDA 017584, manufactured by Fresenius Kabi USA.

FDA has approved ANDA083386 for chlorpromazine hydrochloride tablets (10 mg) manufactured by Upsher‑Smith Laboratories, listed as a prescription oral drug.

FDA granted approval for ANDA076481, a prescription 0.1% mometasone furoate topical ointment manufactured by Encube Ethicals, Inc.

The FDA has approved Primaquine Phosphate, an oral prescription tablet (NDA008316) from Sanofi‑Aventis U.S. LLC, with recent labeling updates in 2025.