Endep

ANDA 85303, held by Roche. Amitriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 85303 (Endep), held by Roche, was first approved by FDA on Dec 27, 1976, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 27, 1976
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 27, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Endep150MG · tablet;oral	Amitriptyline Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jan 17, 1995	Supplement 21Labeling	Approved	None posted
Dec 27, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85303
Drugs@FDA: Overview at FDA
Company: Roche

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters