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FDA NDA · NDA050007

VIBRAMYCIN

Sponsor: PFIZER

APPLICATION
NDA050007
TYPE
NDA
ORIGINAL APPROVAL
1967-12-05
LATEST ACTION
2025-08-08
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

VIBRAMYCIN · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
VIBRAMYCIN · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2025-08-08Labeling · Supplement 40 · standard — Label ↗AP
2025-03-31Labeling · Supplement 39 · standard — Label ↗AP
2019-12-20Labeling · Supplement 34 · standard — Label ↗AP
2018-12-03Labeling · Supplement 33 · standard — Label ↗AP
2017-07-26Labeling · Supplement 32 · standard — Label ↗AP
2016-12-21Labeling · Supplement 31 · standard — Label ↗AP
2016-03-31Labeling · Supplement 30 · standard — Label ↗AP
2015-05-05Manufacturing (CMC) · Supplement 29 — Label ↗AP
2014-10-28Manufacturing (CMC) · Supplement 28AP
2014-09-12Labeling · Supplement 27 · standard — Label ↗AP
2013-09-04Labeling · Supplement 26 · standard — Letter ↗AP
2013-04-29Labeling · Supplement 25 · standard — Letter ↗AP
2011-05-11Labeling · Supplement 23 · standard — Label ↗AP
2008-02-06Labeling · Supplement 20 · standard — Letter ↗AP
2004-03-12Labeling · Supplement 16 · standard — Letter ↗AP
2002-06-18Labeling · Supplement 14 · standard — Letter ↗AP
2002-05-15Manufacturing (CMC) · Supplement 15AP
2000-03-02Manufacturing (CMC) · Supplement 13AP
1992-12-15Efficacy · Supplement 12AP
1992-05-11Labeling · Supplement 10AP
1992-05-11Labeling · Supplement 11AP
1991-08-23Labeling · Supplement 8AP
1991-07-24Manufacturing (CMC) · Supplement 9AP
1967-12-05UNKNOWN · Original · unknownAP
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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.

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