Protriptyline Hydrochloride

ANDA 78913, held by Hikma. Protriptyline Hydrochloride.

As of Nov 14, 2026, ANDA 78913 (Protriptyline Hydrochloride), held by Hikma, was first approved by FDA on Sep 16, 2008, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 16, 2008
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
Sep 16, 2008	Original application	Approved	None posted

Products

2 strengths and forms


Protriptyline Hydrochloride5MG · tablet;oral	Protriptyline Hydrochloride	Discontinued
Protriptyline Hydrochloride10MG · tablet;oral	Protriptyline Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jul 17, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Sep 16, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78913
Drugs@FDA: Overview at FDA
Company: Hikma

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