← FDA DRUG APPROVALS

FDA NDA · NDA050480

VIBRAMYCIN

Sponsor: PFIZER

APPLICATION
NDA050480
TYPE
NDA
ORIGINAL APPROVAL
1974-09-23
LATEST ACTION
2025-08-08
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

VIBRAMYCIN · ReferenceDiscontinued
DOXYCYCLINE CALCIUM EQ 50MG BASE/5ML · SUSPENSION · ORAL

Approval history

2025-08-08Labeling · Supplement 64 · standard — Label ↗AP
2025-03-31Labeling · Supplement 63 · standard — Label ↗AP
2019-12-20Labeling · Supplement 58 · standard — Label ↗AP
2018-12-03Labeling · Supplement 57 · standard — Label ↗AP
2017-07-26Labeling · Supplement 56 · standard — Label ↗AP
2016-12-21Labeling · Supplement 55 · standard — Label ↗AP
2016-03-31Labeling · Supplement 54 · standard — Label ↗AP
2014-09-12Labeling · Supplement 52 · standard — Label ↗AP
2013-09-04Labeling · Supplement 51 · standard — Letter ↗AP
2013-04-29Labeling · Supplement 50 · standard — Letter ↗AP
2011-05-11Labeling · Supplement 47 · standard — Label ↗AP
2008-02-06Labeling · Supplement 42 · standard — Label ↗AP
2004-03-12Labeling · Supplement 37 · standard — Letter ↗AP
2002-06-18Labeling · Supplement 35 · standard — Letter ↗AP
2002-03-01Manufacturing (CMC) · Supplement 36 · standardAP
1992-12-15Efficacy · Supplement 34AP
1992-05-11Labeling · Supplement 6AP
1992-05-11Labeling · Supplement 5AP
1991-08-23Labeling · Supplement 4AP
1983-03-29Labeling · Supplement 1AP
1982-08-31Labeling · Supplement 33AP
1981-09-30Manufacturing (CMC) · Supplement 32 · standardAP
1981-09-29Manufacturing (CMC) · Supplement 31 · standardAP
1981-04-21Manufacturing (CMC) · Supplement 30 · standardAP
1980-09-30Manufacturing (CMC) · Supplement 29 · standardAP
1980-08-12Labeling · Supplement 28AP
1979-10-02Manufacturing (CMC) · Supplement 27 · standardAP
1979-01-10Labeling · Supplement 26AP
1978-11-14Manufacturing (CMC) · Supplement 25 · standardAP
1978-09-25Manufacturing (CMC) · Supplement 24 · standardAP
1978-08-01Manufacturing (CMC) · Supplement 23 · standardAP
1978-07-24Labeling · Supplement 22AP
1978-07-12Labeling · Supplement 21AP
1978-03-13Labeling · Supplement 20AP
1977-11-23Manufacturing (CMC) · Supplement 19 · standardAP
1977-09-30Manufacturing (CMC) · Supplement 18 · standardAP
1977-09-23Manufacturing (CMC) · Supplement 17 · standardAP
1976-09-28Manufacturing (CMC) · Supplement 16 · standardAP
1976-09-27Manufacturing (CMC) · Supplement 15 · standardAP
1976-05-26Manufacturing (CMC) · Supplement 14 · standardAP
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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