Regulatory Updates

FDA has approved the generic oral capsule ANAGRELIDE under ANDA076811, covering 0.5 mg and 1 mg strengths, sponsored by Novitum Pharma and manufactured by ANI Pharmaceuticals.

The FDA has granted approval for Teva Pharmaceuticals' generic carvedilol oral tablets, covering strengths from 3.125 mg to 25 mg under ANDA 076373.

The FDA approved ANDA 085208 for a 50 mg oral tablet of hydrochlorothiazide, now marked as discontinued, with supplemental manufacturing and labeling approvals spanning 1981‑2020.

The FDA has approved Teva Pharmaceuticals’ oral capsule generic of chlordiazepoxide hydrochloride under ANDA 084768, with multiple supplemental manufacturing and labeling approvals.

Epic Pharma LLC filed ANDA078975 for a discontinued topical ciclopirox 8% solution; FDA records show the original submission was approved on 2010-02-17.

FDA approved ANDA077779 for metoprolol succinate extended‑release tablets from NESHER PHARMS; product listed as discontinued.

The FDA has approved labeling for generic levetiracetam tablets, 250 mg to 1 g, from BluePoint Laboratories and Aurobindo Pharma.

The FDA has approved ANDA077507, a generic oral tablet combining glipizide and metformin hydrochloride in three strengths, submitted by EPIC PHARMA LLC.

The FDA has approved Teva Pharmaceuticals’ ANDA 076346 for torsemide oral tablets in 5 mg, 10 mg, 20 mg and 100 mg strengths, prescription‑only.

The FDA lists APRESAZIDE oral capsules (hydralazine HCl 25 mg / hydrochlorothiazide 25 mg) as discontinued, with a series of approved original and supplemental submissions from 1976 to 1998.