← FDA DRUG APPROVALS

FDA NDA · NDA050533

VIBRA-TABS

Sponsor: PFIZER

APPLICATION
NDA050533
TYPE
NDA
ORIGINAL APPROVAL
1980-01-15
LATEST ACTION
2025-08-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VIBRA-TABS · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-08-08Labeling · Supplement 51 · standard — Label ↗AP
2025-03-31Labeling · Supplement 50 · standard — Label ↗AP
2019-12-20Labeling · Supplement 47 · standard — Label ↗AP
2018-12-03Labeling · Supplement 46 · standard — Label ↗AP
2017-07-26Labeling · Supplement 45 · standard — Label ↗AP
2016-12-21Labeling · Supplement 44 · standard — Label ↗AP
2016-03-31Labeling · Supplement 43 · standard — Label ↗AP
2014-09-12Labeling · Supplement 42 · standard — Letter ↗AP
2013-09-04Labeling · Supplement 41 · standard — Letter ↗AP
2013-04-29Labeling · Supplement 40 · standard — Label ↗AP
2011-05-11Labeling · Supplement 38 · standard — Label ↗AP
2008-02-06Labeling · Supplement 36 · standard — Label ↗AP
2004-03-12Labeling · Supplement 32 · standard — Letter ↗AP
2002-06-18Labeling · Supplement 30 · standard — Letter ↗AP
2002-05-15Manufacturing (CMC) · Supplement 31 · standardAP
2000-03-06Manufacturing (CMC) · Supplement 29 · standardAP
1998-05-08Manufacturing (CMC) · Supplement 28 · standardAP
1992-12-15Efficacy · Supplement 27AP
1992-05-11Labeling · Supplement 26AP
1992-05-07Labeling · Supplement 11AP
1991-08-23Labeling · Supplement 9AP
1991-07-24Manufacturing (CMC) · Supplement 10 · standardAP
1984-05-22Manufacturing (CMC) · Supplement 25 · standardAP
1984-02-13Efficacy · Supplement 24AP
1984-01-17Efficacy · Supplement 23AP
1983-11-21Labeling · Supplement 21AP
1983-04-01Labeling · Supplement 20AP
1982-08-31Labeling · Supplement 19AP
1982-04-02Manufacturing (CMC) · Supplement 18 · standardAP
1982-02-25Manufacturing (CMC) · Supplement 16 · standardAP
1982-02-16Manufacturing (CMC) · Supplement 17 · standardAP
1981-12-17Manufacturing (CMC) · Supplement 15 · standardAP
1981-12-15Manufacturing (CMC) · Supplement 14 · standardAP
1981-06-30Manufacturing (CMC) · Supplement 13 · standardAP
1981-04-02Manufacturing (CMC) · Supplement 7 · standardAP
1981-03-11Manufacturing (CMC) · Supplement 12 · standardAP
1981-02-26Manufacturing (CMC) · Supplement 3 · standardAP
1981-02-05Manufacturing (CMC) · Supplement 8 · standardAP
1980-10-21Manufacturing (CMC) · Supplement 6 · standardAP
1980-08-12Labeling · Supplement 5AP
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 →