Janimine

NDA 17895, held by Abbott. Imipramine Hydrochloride.

As of Nov 13, 2026, NDA 17895 (Janimine), held by Abbott, was first approved by FDA on Nov 15, 1974, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 15, 1974
Review: Priority
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Nov 15, 1974	Original applicationTYPE 6 · Priority review	Approved	None posted

Products

3 strengths and forms


Janimine10MG · tablet;oral	Imipramine Hydrochloride	Discontinued
Janimine25MG · tablet;oral	Imipramine Hydrochloride	Discontinued
Janimine50MG · tablet;oral	Imipramine Hydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Sep 12, 1988	Supplement 12Manufacturing · Priority review	Approved	None posted
Dec 14, 1987	Supplement 11Manufacturing · Priority review	Approved	None posted
Dec 13, 1984	Supplement 10Labeling · Priority review	Approved	None posted
Mar 27, 1984	Supplement 9Manufacturing · Priority review	Approved	None posted
Dec 20, 1983	Supplement 8Labeling · Priority review	Approved	None posted
Jul 15, 1983	Supplement 7Manufacturing · Priority review	Approved	None posted
Jun 25, 1981	Supplement 5Manufacturing · Priority review	Approved	None posted
Apr 8, 1977	Supplement 4Labeling · Priority review	Approved	None posted
Nov 15, 1974	Original applicationTYPE 6 · Priority review	Approved	None posted

Identifiers

Application: NDA 17895
Drugs@FDA: Overview at FDA
Company: Abbott

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