← FDA DRUG APPROVALS

FDA NDA · NDA050006

VIBRAMYCIN

Sponsor: PFIZER

APPLICATION
NDA050006
TYPE
NDA
ORIGINAL APPROVAL
1967-12-06
LATEST ACTION
2025-08-08
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

VIBRAMYCIN · ReferenceDiscontinued
DOXYCYCLINE EQ 25MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SUSPENSION · ORAL

Approval history

2025-08-08Labeling · Supplement 96 · standard — Label ↗AP
2025-03-31Labeling · Supplement 95 · standard — Label ↗AP
2019-12-20Labeling · Supplement 92 · standard — Label ↗AP
2018-12-03Labeling · Supplement 91 · standard — Label ↗AP
2017-07-26Labeling · Supplement 89 · standard — Label ↗AP
2016-12-21Labeling · Supplement 88 · standard — Label ↗AP
2016-03-31Labeling · Supplement 87 · standard — Label ↗AP
2014-09-12Labeling · Supplement 86 · standard — Letter ↗AP
2013-09-04Labeling · Supplement 85 · standard — Letter ↗AP
2013-04-29Labeling · Supplement 84 · standard — Letter ↗AP
2011-05-11Labeling · Supplement 82 · standard — Label ↗AP
2008-02-06Labeling · Supplement 79 · standard — Label ↗AP
2004-03-12Labeling · Supplement 76 · standard — Letter ↗AP
2002-06-18Labeling · Supplement 74 · standard — Letter ↗AP
1992-12-15Efficacy · Supplement 73AP
1992-05-11Labeling · Supplement 7AP
1992-05-11Labeling · Supplement 5AP
1991-08-23Labeling · Supplement 4AP
1983-11-21Labeling · Supplement 2AP
1983-03-29Labeling · Supplement 1AP
1982-08-31Labeling · Supplement 72AP
1981-10-20Manufacturing (CMC) · Supplement 70AP
1981-10-19Manufacturing (CMC) · Supplement 71AP
1980-09-17Manufacturing (CMC) · Supplement 69AP
1980-09-16Manufacturing (CMC) · Supplement 68AP
1980-08-12Labeling · Supplement 67AP
1979-09-20Manufacturing (CMC) · Supplement 65AP
1979-09-19Manufacturing (CMC) · Supplement 66AP
1978-10-19Manufacturing (CMC) · Supplement 64AP
1978-07-12Labeling · Supplement 62AP
1978-07-12Labeling · Supplement 63AP
1978-03-13Labeling · Supplement 61AP
1977-09-21Manufacturing (CMC) · Supplement 59AP
1977-09-20Labeling · Supplement 60AP
1977-09-14Manufacturing (CMC) · Supplement 58AP
1976-12-06Manufacturing (CMC) · Supplement 57AP
1976-09-13Manufacturing (CMC) · Supplement 56AP
1976-09-10Manufacturing (CMC) · Supplement 55AP
1976-05-20Manufacturing (CMC) · Supplement 54AP
1976-04-09Manufacturing (CMC) · Supplement 53AP
VIEW ON DRUGS@FDA ↗

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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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