← FDA DRUG APPROVALS

FDA NDA · NDA050442

VIBRAMYCIN

Sponsor: PFIZER

APPLICATION
NDA050442
TYPE
NDA
ORIGINAL APPROVAL
1972-09-05
LATEST ACTION
2017-07-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

VIBRAMYCIN · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
VIBRAMYCIN · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2017-07-26Labeling · Supplement 20 · standard — Label ↗AP
2016-12-21Labeling · Supplement 19 · standard — Label ↗AP
2016-03-31Labeling · Supplement 18 · standard — Letter ↗AP
2014-09-24Labeling · Supplement 17 · standard — Label ↗AP
2013-09-11Labeling · Supplement 16 · standard — Letter ↗AP
2002-06-18Labeling · Supplement 15 · standard — Letter ↗AP
1992-05-11Labeling · Supplement 6AP
1989-08-03Manufacturing (CMC) · Supplement 5AP
1981-05-11Labeling · Supplement 14AP
1978-03-07Labeling · Supplement 12AP
1977-10-03Labeling · Supplement 11AP
1977-09-21Efficacy · Supplement 10AP
1976-09-03Efficacy · Supplement 9AP
1972-12-11Efficacy · Supplement 7AP
1972-09-05UNKNOWN · Original · unknownAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →