Regulatory UpdatesSep 8, 2026•1 min read

FDA Approves ANDA080807 for Diphenhydramine Capsules – IMPAX Labs

By the PharmaCountry team

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

The U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) numbered ANDA080807 submitted by IMPAX Labs. The application covers two oral capsule products containing diphenhydramine hydrochloride: - Product 001: 25 mg diphenhydramine hydrochloride capsule (marketing status: discontinued). - Product 002: 50 mg diphenhydramine hydrochloride capsule (marketing status: discontinued). Submission history shows an original (ORIG) filing (submission number 1) approved on 14 Nov 1973, and a labeling supplement (submission number 34) approved on 18 Oct 1989. No reference drug status or reference standard is indicated for either product. Both products are currently marked as discontinued, indicating they are no longer marketed despite the FDA approvals.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#diphenhydramine #ANDA #FDA #Oral #Capsule #IMPAX Labs