Achromycin

NDA 50276, held by Lederle. Procaine Hydrochloride; Tetracycline Hydrochloride.

As of Nov 14, 2026, NDA 50276 (Achromycin), held by Lederle, was first approved by FDA on Jul 1, 1954, with 36 approved supplements and 0 published complete response letters.

First approved: Jul 1, 1954
Supplements approved: 36
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 37 submissions below

Date	Submission	Status	Documents
Jul 1, 1954	Original application	Approved	None posted

Products

2 strengths and forms


Achromycin40MG/VIAL;100MG/VIAL · injectable;injection	Procaine Hydrochloride; Tetracycline Hydrochloride	Discontinued
Achromycin40MG/VIAL;250MG/VIAL · injectable;injection	Procaine Hydrochloride; Tetracycline Hydrochloride	Discontinued

All 37 submissions, including labeling and manufacturing supplements


Nov 20, 1991	Supplement 10Labeling	Approved	None posted
Nov 20, 1991	Supplement 8Labeling	Approved	None posted
Nov 20, 1991	Supplement 7Labeling	Approved	None posted
Oct 9, 1986	Supplement 45Labeling	Approved	None posted
Sep 30, 1985	Supplement 44Manufacturing	Approved	None posted
Aug 28, 1984	Supplement 43Manufacturing	Approved	None posted
Jul 24, 1984	Supplement 42Manufacturing	Approved	None posted
Mar 22, 1982	Supplement 40Labeling	Approved	None posted
May 12, 1981	Supplement 39Manufacturing	Approved	None posted
Mar 20, 1981	Supplement 38Manufacturing	Approved	None posted
Sep 18, 1979	Supplement 37Manufacturing	Approved	None posted
Jun 7, 1978	Supplement 36Labeling	Approved	None posted
Jan 13, 1975	Supplement 35Manufacturing	Approved	None posted
Apr 26, 1974	Supplement 34Manufacturing	Approved	None posted
Oct 21, 1973	Supplement 32Manufacturing	Approved	None posted
Jun 21, 1973	Supplement 33Labeling	Approved	None posted
Jun 21, 1973	Supplement 30Labeling	Approved	None posted
Jan 5, 1971	Supplement 31Labeling	Approved	None posted
Jan 5, 1966	Supplement 28Labeling	Approved	None posted
Aug 12, 1964	Supplement 27Labeling	Approved	None posted
Oct 24, 1963	Supplement 26Manufacturing	Approved	None posted
May 27, 1963	Supplement 25Labeling	Approved	None posted
Oct 30, 1961	Supplement 22Labeling	Approved	None posted
Apr 7, 1961	Supplement 21Labeling	Approved	None posted
Mar 13, 1961	Supplement 20Manufacturing	Approved	None posted
Mar 17, 1960	Supplement 19Labeling	Approved	None posted
Jan 14, 1960	Supplement 16Manufacturing	Approved	None posted
Jul 31, 1959	Supplement 18Manufacturing	Approved	None posted
Feb 6, 1959	Supplement 17Manufacturing	Approved	None posted
Aug 18, 1958	Supplement 15Labeling	Approved	None posted
Aug 18, 1958	Supplement 14Labeling	Approved	None posted
Apr 19, 1957	Supplement 6Labeling	Approved	None posted
Jul 18, 1955	Supplement 13Manufacturing	Approved	None posted
Mar 4, 1955	Supplement 5Manufacturing	Approved	None posted
Nov 29, 1954	Supplement 3Manufacturing	Approved	None posted
Sep 24, 1954	Supplement 2Labeling	Approved	None posted
Jul 1, 1954	Original application	Approved	None posted

Identifiers

Application: NDA 50276
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