Regulatory UpdatesAug 25, 2026•1 min read

FDA Approves ANDA086746 for Amitriptyline Tablet – Lederle

By the PharmaCountry team

FDA approved application ANDA086746 for an oral amitriptyline hydrochloride 25 mg tablet submitted by Lederle; the product is listed as discontinued.

The U.S. Food and Drug Administration (FDA) has approved application number ANDA086746 submitted by Lederle. The approval pertains to an oral tablet formulation of amitriptyline hydrochloride at a strength of 25 mg. The product is identified as "AMITRIPTYLINE HYDROCHLORIDE" with a product number 001 and is currently marked as discontinued. The submission was classified as a supplemental (SUPPL) filing, submission number 2, with a status of AP (approved). It falls under the manufacturing (CMC) category, with the submission status date recorded as March 15, 1982. No reference drug or reference standard was indicated for this product.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#Amitriptyline #ANDA #FDA #Oral Tablet #manufacturing #Lederle