Vibramycin

NDA 50007, held by Pfizer. Doxycycline Hyclate.

As of Nov 14, 2026, NDA 50007 (Vibramycin), held by Pfizer, was first approved by FDA on Dec 5, 1967, with 23 approved supplements and 0 published complete response letters.

First approved: Dec 5, 1967
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below


Dec 15, 1992	Supplement 12Efficacy (new indication or use)	Approved	None posted
Dec 5, 1967	Original application	Approved	None posted

Products

2 strengths and forms


VibramycinEQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Doxycycline Hyclate	DiscontinuedReference drug
VibramycinEQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Doxycycline Hyclate	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Aug 8, 2025	Supplement 40Labeling · Standard review	Approved	Letter Label
Mar 31, 2025	Supplement 39Labeling · Standard review	Approved	Letter Label
Dec 20, 2019	Supplement 34Labeling · Standard review	Approved	Letter Label
Dec 3, 2018	Supplement 33Labeling · Standard review	Approved	Letter Label
Jul 26, 2017	Supplement 32Labeling · Standard review	Approved	Letter Label
Dec 21, 2016	Supplement 31Labeling · Standard review	Approved	Letter Label
Mar 31, 2016	Supplement 30Labeling · Standard review	Approved	Label Letter
May 5, 2015	Supplement 29Manufacturing	Approved	Label
Oct 28, 2014	Supplement 28Manufacturing	Approved	None posted
Sep 12, 2014	Supplement 27Labeling · Standard review	Approved	Label Letter
Sep 4, 2013	Supplement 26Labeling · Standard review	Approved	Letter Label
Apr 29, 2013	Supplement 25Labeling · Standard review	Approved	Letter Label
May 11, 2011	Supplement 23Labeling · Standard review	Approved	Label
Feb 6, 2008	Supplement 20Labeling · Standard review	Approved	Label Letter
Mar 12, 2004	Supplement 16Labeling · Standard review	Approved	Letter
Jun 18, 2002	Supplement 14Labeling · Standard review	Approved	Letter
May 15, 2002	Supplement 15Manufacturing	Approved	None posted
Mar 2, 2000	Supplement 13Manufacturing	Approved	None posted
Dec 15, 1992	Supplement 12Efficacy (new indication or use)	Approved	None posted
May 11, 1992	Supplement 11Labeling	Approved	None posted
May 11, 1992	Supplement 10Labeling	Approved	None posted
Aug 23, 1991	Supplement 8Labeling	Approved	None posted
Jul 24, 1991	Supplement 9Manufacturing	Approved	None posted
Dec 5, 1967	Original application	Approved	None posted

Identifiers

Application: NDA 50007
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