Achromycin

NDA 50273, held by Lederle. Tetracycline Hydrochloride.

As of Nov 13, 2026, NDA 50273 (Achromycin), held by Lederle, was first approved by FDA on Nov 19, 1953, with 26 approved supplements and 0 published complete response letters.

First approved: Nov 19, 1953
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Nov 19, 1953	Original application	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Achromycin250MG/VIAL · injectable;injection	Tetracycline Hydrochloride	Discontinued
Achromycin500MG/VIAL · injectable;injection	Tetracycline Hydrochloride	Discontinued

All 27 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 20, 1991	Supplement 9Labeling	Approved	None posted
Nov 15, 1991	Supplement 7Labeling	Approved	None posted
Nov 15, 1991	Supplement 6Labeling	Approved	None posted
Oct 16, 1986	Supplement 5Manufacturing	Approved	None posted
Oct 9, 1986	Supplement 4Labeling	Approved	None posted
Sep 30, 1985	Supplement 3Manufacturing	Approved	None posted
Jan 25, 1984	Supplement 1Manufacturing	Approved	None posted
Mar 22, 1982	Supplement 29Manufacturing	Approved	None posted
Jan 27, 1982	Supplement 28Manufacturing	Approved	None posted
May 12, 1981	Supplement 27Manufacturing	Approved	None posted
Aug 28, 1979	Supplement 26Manufacturing	Approved	None posted
Apr 12, 1978	Supplement 25Labeling	Approved	None posted
Apr 26, 1974	Supplement 24Manufacturing	Approved	None posted
Jul 23, 1973	Supplement 23Manufacturing	Approved	None posted
Jul 2, 1973	Supplement 22Labeling	Approved	None posted
Aug 31, 1971	Supplement 21Manufacturing	Approved	None posted
Oct 11, 1968	Supplement 20Manufacturing	Approved	None posted
Jan 27, 1967	Supplement 19Labeling	Approved	None posted
Sep 13, 1961	Supplement 18Manufacturing	Approved	None posted
Apr 5, 1960	Supplement 17Manufacturing	Approved	None posted
Jun 9, 1958	Supplement 16Manufacturing	Approved	None posted
Mar 3, 1955	Supplement 15Labeling	Approved	None posted
Oct 27, 1954	Supplement 14Manufacturing	Approved	None posted
Apr 22, 1954	Supplement 13Manufacturing	Approved	None posted
Apr 13, 1954	Supplement 12Manufacturing	Approved	None posted
Jan 26, 1954	Supplement 11Labeling	Approved	None posted
Nov 19, 1953	Original application	Approved	None posted

Identifiers

Application: NDA 50273
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