Elavil

NDA 12704, held by Astrazeneca. Amitriptyline Hydrochloride.

As of Nov 13, 2026, NDA 12704 (Elavil), held by Astrazeneca, was first approved by FDA on Apr 11, 1961, with 25 approved supplements and 0 published complete response letters.

First approved: Apr 11, 1961
Review: Standard
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Apr 11, 1961	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Elavil10MG/ML · injectable;injection	Amitriptyline Hydrochloride	Discontinued

All 26 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 29, 2003	Supplement 46Labeling · Standard review	Approved	Letter
Mar 27, 2001	Supplement 45Labeling · Standard review	Approved	Letter
Apr 5, 2000	Supplement 44Labeling · Standard review	Approved	None posted
Apr 5, 2000	Supplement 42Labeling · Standard review	Approved	None posted
Apr 5, 2000	Supplement 41Labeling · Standard review	Approved	None posted
Apr 5, 2000	Supplement 40Labeling · Standard review	Approved	None posted
Apr 5, 2000	Supplement 39Labeling · Standard review	Approved	None posted
Dec 24, 1998	Supplement 43Manufacturing · Standard review	Approved	None posted
Oct 2, 1995	Supplement 26Manufacturing · Standard review	Approved	None posted
Jun 24, 1991	Supplement 35Labeling · Standard review	Approved	None posted
Jun 24, 1991	Supplement 33Labeling · Standard review	Approved	None posted
Jul 28, 1989	Supplement 36Manufacturing · Standard review	Approved	None posted
Dec 12, 1988	Supplement 34Manufacturing · Standard review	Approved	None posted
Jul 10, 1986	Supplement 32Labeling · Standard review	Approved	None posted
Sep 20, 1985	Supplement 31Labeling · Standard review	Approved	None posted
May 21, 1984	Supplement 28Labeling · Standard review	Approved	None posted
Mar 15, 1983	Supplement 30Labeling · Standard review	Approved	None posted
Jun 25, 1981	Supplement 25Manufacturing · Standard review	Approved	None posted
Mar 23, 1981	Supplement 24Labeling · Standard review	Approved	None posted
Mar 9, 1981	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 2, 1981	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 2, 1981	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 3, 1980	Supplement 23Labeling · Standard review	Approved	None posted
Jun 23, 1980	Supplement 22Labeling · Standard review	Approved	None posted
Mar 4, 1980	Supplement 19Labeling · Standard review	Approved	None posted
Apr 11, 1961	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 12704
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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