FDA Approves ANDA 084640 for DIPHEN Oral Elixir (USL Pharma)

The U.S. Food and Drug Administration has an approved Abbreviated New Drug Application (ANDA) numbered 084640 for the oral elixir product DIPHEN, marketed by USL Pharma. The product is formulated as an oral elixir containing diphenhydramine hydrochloride at a strength of 12.5 mg per 5 mL. DIPHEN is listed with a discontinued marketing status, indicating it is no longer commercially available. The original ANDA (submission type ORIG, submission number 1) received approval on February 26, 1979. Since then, the FDA has approved a series of supplemental manufacturing (CMC) submissions (submission numbers 13, 14, 15, 17, 19, 20, 23, 24, and 8) between 1983 and 1987, each marked as approved (status "AP"). These supplemental filings reflect ongoing manufacturing and compliance updates for the product, even though its marketing status remains discontinued. The active ingredient, diphenhydramine hydrochloride, is a common antihistamine used in various formulations. Stakeholders should note the product’s discontinued status while referencing the approved ANDA and its supplemental history for regulatory and compliance purposes.