規制動向

FDA listed ANDA083183 for diphenhydramine hydrochloride injection (50 mg/mL) from sponsor Hikma; approved on 12 Oct 1973, marketing status discontinued.

FDA granted labeling approval for HIKMA Farmaceutica's ciprofloxacin 400 mg/200 mL injection under ANDA078431, with multiple supplemental approvals since 2009.

The FDA has approved ANDA 078713 for Hikma’s injectable Indomethacin Sodium, though the product is listed as discontinued.

The FDA approved HIKMA's ANDA062720 for cephapirin sodium injectable products, all listed as discontinued, with approval dated July 2, 1987.

FDA granted approval for Hikma's deferoxamine mesylate injectable products (ANDA078086), available in 500 mg and 2 g vials, both listed as discontinued.

The FDA has granted approval for ANDA080445, covering multiple injectable strengths of meperidine hydrochloride manufactured by Hikma Pharmaceuticals USA.

FDA approved Hikma's ANDA 079217 for oral Dronabinol capsules (2.5 mg, 5 mg, 10 mg); all listed products are currently marked discontinued.

FDA approved Hikma International Pharmaceutics' generic lithium carbonate 300 mg tablet (ANDA 078715) on Dec 28 2010, with a labeling supplement approved in 2012.

FDA has approved Hikma's Granisetron Hydrochloride injectable (ANDA077177) with labeling updates in 2014 and 2022, confirming its prescription status.