규제 업데이트

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.

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.

The FDA has granted several labeling approvals for Chartwell Rx’s desloratadine 5 mg oral tablet (ANDA078364), though the product is listed as discontinued.

FDA granted approval for CALCITRIOL injectable products (ANDA078066) from LONG GROVE PHARMS, including a prescription 0.001 mg/mL product and a discontinued 0.002 mg/mL version.

The FDA granted approval for Chartwell Rx's ANDA077766, covering five discontinued Simvastatin tablet strengths and subsequent labeling updates.

Teva Pharmaceuticals’ oral ramipril capsule products (1.25‑10 mg) were listed as discontinued, with multiple FDA labeling supplements approved between 2008 and 2014.

FDA approved ANDA076589 submitted by Dr Reddys, covering two injectable FLUMAZENIL products, both listed with discontinued marketing status.