Achromycin V

Treats infections caused by susceptible strains of the designated organisms in the…. NDA 50278, held by Avet. Tetracycline Hydrochloride.

As of Nov 13, 2026, NDA 50278 (Achromycin V), held by Avet, was first approved by FDA on Oct 8, 1957, with 21 approved supplements and 0 published complete response letters.

First approved: Oct 8, 1957
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Oct 8, 1957	Original application	Approved	None posted

Products

2 strengths and forms


Achromycin V500MG · capsule;oral	Tetracycline Hydrochloride	RxReference drug
Achromycin V250MG · capsule;oral	Tetracycline Hydrochloride	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


Mar 31, 2025	Supplement 49Labeling · Standard review	Approved	Letter Label
Jul 21, 2016	Supplement 39Manufacturing	Approved	None posted
May 19, 2016	Supplement 40Manufacturing	Approved	None posted
Apr 27, 2015	Supplement 37Labeling · Standard review	Approved	Label Letter
Apr 21, 2015	Supplement 36Manufacturing	Approved	None posted
Mar 17, 1999	Supplement 33Manufacturing	Approved	None posted
May 15, 1992	Supplement 17Manufacturing	Approved	None posted
Nov 15, 1991	Supplement 12Labeling	Approved	None posted
Mar 20, 1990	Supplement 15Manufacturing	Approved	None posted
Oct 26, 1961	Supplement 32Labeling	Approved	None posted
Mar 16, 1961	Supplement 31Labeling	Approved	None posted
Jan 16, 1961	Supplement 30Manufacturing	Approved	None posted
Dec 20, 1960	Supplement 28Manufacturing	Approved	None posted
Dec 2, 1960	Supplement 27Manufacturing	Approved	None posted
Sep 22, 1959	Supplement 26Manufacturing	Approved	None posted
Feb 13, 1959	Supplement 25Manufacturing	Approved	None posted
Oct 1, 1958	Supplement 24Manufacturing	Approved	None posted
Sep 15, 1958	Supplement 22Labeling	Approved	None posted
Sep 15, 1958	Supplement 23Labeling	Approved	None posted
May 28, 1958	Supplement 21Labeling	Approved	None posted
Apr 25, 1958	Supplement 20Manufacturing	Approved	None posted
Oct 8, 1957	Original application	Approved	None posted

Identifiers

Application: NDA 50278
Drugs@FDA: Overview at FDA
Company: Avet Pharmaceuticals

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