Limbitrol, Limbitrol Ds

NDA 16949, held by Chartwell Rx. Amitriptyline Hydrochloride; Chlordiazepoxide.

As of Nov 13, 2026, NDA 16949 (Limbitrol, Limbitrol Ds), held by Chartwell Rx, was first approved by FDA on Dec 23, 1977, with 35 approved supplements and 0 published complete response letters.

First approved: Dec 23, 1977
Review: Standard
Supplements approved: 35
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below

Date	Submission	Status	Documents
Dec 23, 1977	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
LimbitrolEQ 12.5MG BASE;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amitriptyline Hydrochloride; Chlordiazepoxide	DiscontinuedReference drug
Limbitrol DsEQ 25MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amitriptyline Hydrochloride; Chlordiazepoxide	DiscontinuedReference drug

All 36 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 24, 2025	Supplement 44Labeling · Standard review	Approved	Label Medication Guide Letter
Oct 28, 2024	Supplement 43Labeling · Standard review	Approved	Letter Label
Jan 13, 2023	Supplement 42Labeling · Standard review	Approved	Letter Label
Feb 5, 2021	Supplement 41Labeling	Approved	Label Letter
Dec 16, 2016	Supplement 40Labeling	Approved	Letter Label
Apr 25, 2016	Supplement 39Labeling	Approved	Label Letter
Aug 3, 2007	Supplement 38Labeling · Standard review	Approved	Letter Label
Jan 12, 2005	Supplement 35Labeling · Standard review	Approved	Letter Label
Dec 19, 2001	Supplement 34Manufacturing · Standard review	Approved	None posted
Jun 5, 2001	Supplement 33Labeling · Standard review	Approved	Letter
Mar 28, 2000	Supplement 32Labeling · Standard review	Approved	None posted
Mar 28, 2000	Supplement 31Labeling · Standard review	Approved	None posted
Mar 28, 2000	Supplement 27Labeling	Approved	None posted
Dec 28, 1992	Supplement 29Manufacturing · Standard review	Approved	None posted
Jan 16, 1990	Supplement 28Manufacturing · Standard review	Approved	None posted
Jun 9, 1988	Supplement 26Manufacturing · Standard review	Approved	None posted
Nov 19, 1985	Supplement 25Labeling	Approved	None posted
Apr 17, 1985	Supplement 24Labeling	Approved	None posted
Jun 26, 1984	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 20, 1982	Supplement 20Manufacturing · Standard review	Approved	None posted
Sep 20, 1982	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 22, 1982	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 9, 1980	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 9, 1980	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 9, 1980	Supplement 1Manufacturing · Standard review	Approved	None posted
May 19, 1980	Supplement 14Manufacturing · Standard review	Approved	None posted
May 19, 1980	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 28, 1980	Supplement 13Labeling	Approved	None posted
Jan 21, 1980	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 7, 1979	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 15, 1979	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 25, 1978	Supplement 9Labeling	Approved	None posted
Aug 22, 1978	Supplement 6Manufacturing · Standard review	Approved	None posted
Jul 24, 1978	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 17, 1978	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 23, 1977	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 16949
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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