Regulatory Updates

The FDA has issued labeling approvals for ANDA078380, a 20 mg sildenafil citrate tablet by Teva Pharmaceuticals, now listed as discontinued.

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 ANDA217961 for CARBIDOPA 25 mg oral tablets, a prescription product submitted by Regcon Holdings.

The FDA granted approval (AP) for Bionpharma Inc.’s nicardipine hydrochloride oral capsules, 20 mg and 30 mg strengths, under application ANDA217555.

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.

The FDA's recent ANDA 210602 approval includes a range of ibuprofen oral suspension products, covering dye‑free, kosher, and flavored versions for OTC use.

The FDA has approved ANDA210245 submitted by MSN for generic pomalidomide capsules in 2 mg, 3 mg, and 4 mg strengths.

The FDA has approved ANDA209591 for a prescription oral tablet combining amlodipine besylate and olmesartan medoxomil, sponsored by Hetero Labs.

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

The FDA approved ANDA209242 for Camber’s prescription oral tablet combining olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in multiple strengths.

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