규제 업데이트

The FDA has listed ANDA086088 for Hydralazine Hydrochloride 25 mg oral tablets submitted by Vitarine, noting the product is discontinued.

FDA records show PROVAL #3 oral capsule, containing 325 mg acetaminophen and 30 mg codeine phosphate, is now discontinued. Sponsor: Solvay. ANDA085685.

The FDA’s ANDA 085195 for Watson Labs’ oral Meclizine Hydrochloride 12.5 mg tablet is marked discontinued, indicating the product is no longer marketed.

The FDA has approved ANDA084731 for Theophylline capsules in 100 mg, 200 mg and 250 mg strengths. All three products are listed as discontinued by sponsor Scherer RP.

The FDA’s ANDA084259 for a 500 mg methocarbamol oral tablet, sponsored by Mylan, is listed as discontinued.

The FDA's ANDA090265, submitted by CARACO, received approval on Dec 23, 2008 for three oral hydrocodone bitartrate/acetaminophen tablet strengths, now listed as discontinued.

A Korean citizen petition urges the government to scrap plans to expand non‑face‑to‑face prescription drug delivery, citing health‑insurance strain and safety concerns.

FDA records show Quad Pharms' Isoniazid injectable (100 mg/mL) under ANDA089816 is marked as discontinued.

FDA records indicate the oral Hydroxyzine Hydrochloride 50 mg tablet (product 001) is discontinued, with multiple manufacturing and labeling submissions approved between 1989 and 2016.

CENCI's PROMETHAZINE oral syrup (product 001) is listed as discontinued in the FDA ANDA089013 filing.

The FDA has approved ANDA 078962 for Betaxolol Hydrochloride oral tablets, 10 mg and 20 mg, manufactured by KVK TECH. Both products are prescription‑only.

FDA has approved ANDA078654 submitted by SUN PHARM INDS INC for clonazepam orally disintegrating tablets across several strengths; all listed products are currently discontinued.