Declomycin

NDA 50257, held by Lederle. Demeclocycline Hydrochloride.

As of Nov 14, 2026, NDA 50257 (Declomycin), held by Lederle, was first approved by FDA on Nov 14, 1960, with 52 approved supplements and 0 published complete response letters.

First approved: Nov 14, 1960
Supplements approved: 52
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 53 submissions below

Date	Submission	Status	Documents
Nov 14, 1960	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Declomycin75MG/5ML · syrup;oral	Demeclocycline Hydrochloride	Discontinued

All 53 submissions, including labeling and manufacturing supplements


Sep 25, 1978	Supplement 56Manufacturing	Approved	None posted
Jun 7, 1978	Supplement 55Labeling	Approved	None posted
Feb 28, 1976	Supplement 54Manufacturing	Approved	None posted
Feb 28, 1974	Supplement 53Labeling	Approved	None posted
Oct 10, 1973	Supplement 52Labeling	Approved	None posted
Oct 1, 1973	Supplement 51Labeling	Approved	None posted
Feb 22, 1972	Supplement 50Manufacturing	Approved	None posted
Jan 10, 1972	Supplement 48Labeling	Approved	None posted
Jan 10, 1972	Supplement 49Labeling	Approved	None posted
Jul 14, 1971	Supplement 47Labeling	Approved	None posted
Apr 13, 1971	Supplement 44Labeling	Approved	None posted
Oct 18, 1970	Supplement 46Labeling	Approved	None posted
Apr 24, 1970	Supplement 45Manufacturing	Approved	None posted
Feb 10, 1970	Supplement 43Manufacturing	Approved	None posted
Nov 12, 1969	Supplement 40Labeling	Approved	None posted
Nov 12, 1969	Supplement 42Labeling	Approved	None posted
Aug 29, 1969	Supplement 41Manufacturing	Approved	None posted
Oct 26, 1967	Supplement 39Labeling	Approved	None posted
Sep 21, 1967	Supplement 38Labeling	Approved	None posted
Apr 5, 1967	Supplement 37Labeling	Approved	None posted
Dec 30, 1966	Supplement 35Labeling	Approved	None posted
Dec 15, 1966	Supplement 33Labeling	Approved	None posted
Nov 4, 1966	Supplement 34Manufacturing	Approved	None posted
Oct 21, 1966	Supplement 31Labeling	Approved	None posted
Jan 5, 1966	Supplement 30Labeling	Approved	None posted
Jan 26, 1965	Supplement 29Labeling	Approved	None posted
Dec 14, 1964	Supplement 27Labeling	Approved	None posted
Dec 14, 1964	Supplement 28Labeling	Approved	None posted
Aug 17, 1964	Supplement 26Labeling	Approved	None posted
Jul 14, 1964	Supplement 25Labeling	Approved	None posted
Jun 23, 1964	Supplement 24Labeling	Approved	None posted
Jan 23, 1964	Supplement 23Labeling	Approved	None posted
Jan 15, 1964	Supplement 22Labeling	Approved	None posted
Jan 8, 1964	Supplement 21Labeling	Approved	None posted
Nov 12, 1963	Supplement 20Labeling	Approved	None posted
May 27, 1963	Supplement 18Labeling	Approved	None posted
May 27, 1963	Supplement 19Labeling	Approved	None posted
Jan 3, 1963	Supplement 16Manufacturing	Approved	None posted
Sep 14, 1962	Supplement 15Labeling	Approved	None posted
Jul 26, 1962	Supplement 9Labeling	Approved	None posted
Jul 26, 1962	Supplement 10Labeling	Approved	None posted
Jul 26, 1962	Supplement 11Labeling	Approved	None posted
Jun 27, 1962	Supplement 12Labeling	Approved	None posted
Jun 27, 1962	Supplement 13Labeling	Approved	None posted
Apr 11, 1962	Supplement 8Labeling	Approved	None posted
Feb 9, 1962	Supplement 7Labeling	Approved	None posted
Oct 30, 1961	Supplement 6Labeling	Approved	None posted
Oct 21, 1961	Supplement 5Labeling	Approved	None posted
May 16, 1961	Supplement 4Labeling	Approved	None posted
Apr 5, 1961	Supplement 3Labeling	Approved	None posted
Nov 28, 1960	Supplement 1Labeling	Approved	None posted
Nov 28, 1960	Supplement 2Labeling	Approved	None posted
Nov 14, 1960	Original application	Approved	None posted

Show all 53

Identifiers

Application: NDA 50257
Drugs@FDA: Overview at FDA
Company: Lederle Laboratories

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