← FDA DRUG APPROVALS

FDA NDA · NDA050649

MINOCIN

Sponsor: BAUSCH

APPLICATION
NDA050649
TYPE
NDA
ORIGINAL APPROVAL
1990-05-31
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued, Prescription

Products

MINOCIN · ReferenceDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
MINOCIN · ReferencePrescription
MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
MINOCIN · ReferencePrescription
MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE · CAPSULE · ORAL

Approval history

2025-03-31Labeling · Supplement 29 · standard — Label ↗AP
2024-07-18Labeling · Supplement 28 · standard — Letter ↗AP
2017-07-19Labeling · Supplement 27 · standard — Label ↗AP
2016-12-14Labeling · Supplement 26 · standard — Letter ↗AP
2015-03-09Labeling · Supplement 25 · standard — Label ↗AP
2014-05-29Manufacturing (CMC) · Supplement 24 · standardAP
2010-09-14Labeling · Supplement 23 · unknown — Label ↗AP
2008-06-30Labeling · Supplement 22 · standard — Label ↗AP
2007-05-30Manufacturing (CMC) · Supplement 21 — Letter ↗AP
2007-04-02Labeling · Supplement 19 · standard — Letter ↗AP
2007-01-23Labeling · Supplement 20 · standard — Label ↗AP
2005-09-28Labeling · Supplement 18 · standard — Letter ↗AP
2005-02-17Labeling · Supplement 15 · standard — Letter ↗AP
2004-05-27Labeling · Supplement 17 · standard — Letter ↗AP
2004-05-27Labeling · Supplement 16 · standard — Letter ↗AP
2002-05-31Labeling · Supplement 11 · standard — Review ↗AP
2002-02-01Labeling · Supplement 7 · standard — Letter ↗AP
2002-02-01Labeling · Supplement 5 · standard — Letter ↗AP
2002-01-28Manufacturing (CMC) · Supplement 14 · standardAP
2001-03-29Manufacturing (CMC) · Supplement 12 · standardAP
2001-02-12Manufacturing (CMC) · Supplement 13 · standardAP
1998-08-05Manufacturing (CMC) · Supplement 10 · standardAP
1998-08-05Manufacturing (CMC) · Supplement 8 · standardAP
1998-08-05Manufacturing (CMC) · Supplement 9 · standardAP
1995-08-08Labeling · Supplement 6 · standardAP
1993-01-28Manufacturing (CMC) · Supplement 4 · standardAP
1992-05-12Labeling · Supplement 3AP
1992-03-26Labeling · Supplement 2AP
1991-10-09Manufacturing (CMC) · Supplement 1 · standardAP
1990-05-31Type 3 - New Dosage Form · Original · 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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