Regulatorische Updates

The FDA’s ANDA080195 filing shows that MILES’ injectable potassium chloride products (1–4 mEq/mL) are listed as discontinued.

The FDA has approved Sandoz’s over‑the‑counter children’s cetirizine hydrochloride chewable tablets (5 mg and 10 mg) under ANDA 078692.

FDA approved application ANDA078102 submitted by TARO for meloxicam tablets (7.5 mg and 15 mg). Both products are listed with discontinued marketing status.

The FDA granted a Tentative Approval for Dr Reddys Labs' ANDA 077798, covering oral tablets of Escitalopram Oxalate in 5 mg, 10 mg, and 20 mg strengths.

The FDA has approved a series of supplemental submissions for the oral tablet Amitriptyline Hydrochloride (product 002), originally approved in 1977, now listed as discontinued.

The FDA has approved Teva Pharmaceuticals' generic chlordiazepoxide hydrochloride oral capsules (ANDA 084769) with 25 mg strength and multiple NDC codes.

The FDA granted approval for ANDA 085231, an oral tablet containing 25 mg pyrilamine maleate, submitted by Watson Labs. The product is listed as discontinued.

Epic Pharma LLC's ANDA076347 for prescription oral tablets of Tizanidine Hydrochloride (2 mg and 4 mg) has been approved by the FDA, with labeling submissions approved between 2007 and 2016.

The FDA has approved ANDA077510 for Colestipol Hydrochloride 1 g tablets, manufactured by Amneal Pharmaceuticals and sponsored by IMPAX Labs.

FDA's ANDA 076901 for MirtaZAPINE includes three discontinued oral tablet strengths and a series of approved labeling supplements dating from 2005 to 2025.

FDA's ANDA 084640 for DIPHEN oral elixir, containing diphenhydramine hydrochloride 12.5 mg/5 mL, was approved for USL Pharma with multiple manufacturing supplements; the product is now discontinued.

Watson Labs' diphenhydramine hydrochloride injectable (product 001) is recorded by the FDA under ANDA083533 as discontinued and not a reference drug.