Regulatory Updates

FDA granted approval for ANDA214219 covering oral Triazolam tablets (0.125 mg and 0.25 mg) manufactured by Ingenus Pharmaceuticals, LLC.

The FDA has approved Aurobindo Pharma's LIDOCAINE 5% topical ointment (ANDA217117) for prescription use, with a standard review completed on June 18, 2024.

The FDA has approved Alembic Pharmaceuticals’ generic Nitrofurantoin capsules (ANDA211935) for oral prescription use in 25 mg, 50 mg, and 100 mg strengths.

The FDA has approved ANDA211623 for carbamazepine extended‑release tablets (100 mg, 200 mg, 400 mg) submitted by Unique Pharm, with labeling cleared in Jan 2024.

Pharmobedient received FDA approval (ANDA209932) for its magnesium sulfate 5% injection in a plastic container, designated as a prescription product.

The FDA has approved Torrent Pharmaceuticals' generic esomeprazole magnesium delayed‑release oral suspension (ANDA212652), a prescription oral drug with 10 mg base per packet.

The FDA approved ANDA079044 for a nicotine polacrilex chewing gum marketed as an over‑the‑counter product, with multiple manufacturers listed.

The FDA has approved ANDA078728 for oral tablets combining glipizide and metformin HCl, manufactured by Heritage Pharmaceuticals.

FDA granted labeling approval for HIKMA Farmaceutica's ciprofloxacin 400 mg/200 mL injection under ANDA078431, with multiple supplemental approvals since 2009.

The FDA has approved ANDA087315 submitted by Alpharma US Pharms for a 1% hydrocortisone topical lotion, currently listed as discontinued.

The FDA has granted approval for ANDA078039 submitted by CR DOUBLE CRANE for meloxicam oral tablets in 7.5 mg and 15 mg strengths. Both products are listed as discontinued.

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