Regulatory UpdatesAug 25, 2026•1 min read

FDA Lists ENDEP Amitriptyline Tablet Products (ANDA083639)

By the PharmaCountry team

FDA’s ANDA083639 lists five ENDEP oral amitriptyline tablets (10‑100 mg) from Roche, all marked discontinued.

The FDA’s database for drug approvals includes an Abbreviated New Drug Application (ANDA) numbered ANDA083639 submitted by Roche. The application covers the brand name ENDEP, an oral tablet formulation of amitriptyline hydrochloride. The ANDA lists five product variants, each with a distinct strength—10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. All five tablets are designated as “Discontinued” in marketing status, indicating they are no longer marketed.

Compiled by the PharmaCountry team · Source: FDA.gov