Actualités réglementaires

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

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.

The FDA has approved application ANDA205336 for a prescription diphenhydramine hydrochloride injectable (50 mg/mL) product marketed by Avet Lifesciences for IM and IV use.

FDA granted approval for ANDA080800, a 50 mg diphenhydramine hydrochloride oral capsule submitted by Whiteworth Town Plsn; the product is listed as discontinued.

FDA approved ANDA080807 submitted by IMPAX Labs for oral diphenhydramine hydrochloride capsules (25 mg and 50 mg). Both products are listed as discontinued.

FDA ANDA083061 lists two oral diphenhydramine hydrochloride capsule products (25 mg and 50 mg) from Perrigo, both marked discontinued.