Vibramycin

NDA 50442, held by Pfizer. Doxycycline Hyclate.

As of Nov 14, 2026, NDA 50442 (Vibramycin), held by Pfizer, was first approved by FDA on Sep 5, 1972, with 14 approved supplements and 0 published complete response letters.

First approved: Sep 5, 1972
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below


Sep 21, 1977	Supplement 10Efficacy (new indication or use)	Approved	None posted
Sep 3, 1976	Supplement 9Efficacy (new indication or use)	Approved	None posted
Dec 11, 1972	Supplement 7Efficacy (new indication or use)	Approved	None posted
Sep 5, 1972	Original application	Approved	None posted

Products

2 strengths and forms


VibramycinEQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Doxycycline Hyclate	DiscontinuedReference drug
VibramycinEQ 100MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Doxycycline Hyclate	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Jul 26, 2017	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 21, 2016	Supplement 19Labeling · Standard review	Approved	Letter Label
Mar 31, 2016	Supplement 18Labeling · Standard review	Approved	Label Letter
Sep 24, 2014	Supplement 17Labeling · Standard review	Approved	Label Letter
Sep 11, 2013	Supplement 16Labeling · Standard review	Approved	Label Letter
Jun 18, 2002	Supplement 15Labeling · Standard review	Approved	Letter
May 11, 1992	Supplement 6Labeling	Approved	None posted
Aug 3, 1989	Supplement 5Manufacturing	Approved	None posted
May 11, 1981	Supplement 14Labeling	Approved	None posted
Mar 7, 1978	Supplement 12Labeling	Approved	None posted
Oct 3, 1977	Supplement 11Labeling	Approved	None posted
Sep 21, 1977	Supplement 10Efficacy (new indication or use)	Approved	None posted
Sep 3, 1976	Supplement 9Efficacy (new indication or use)	Approved	None posted
Dec 11, 1972	Supplement 7Efficacy (new indication or use)	Approved	None posted
Sep 5, 1972	Original application	Approved	None posted

Identifiers

Application: NDA 50442
Drugs@FDA: Overview at FDA
Company: Pfizer

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