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FDA NDA · NDA050445

MINOCIN

Sponsor: BAUSCH

APPLICATION
NDA050445
TYPE
NDA
ORIGINAL APPROVAL
1972-10-26
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

MINOCINDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE/5ML · SUSPENSION · ORAL

Approval history

2025-03-31Labeling · Supplement 32 · standard — Label ↗AP
2024-07-18Labeling · Supplement 31 · standard — Letter ↗AP
2018-11-16Labeling · Supplement 30 · standard — Label ↗AP
2015-02-25Labeling · Supplement 29 · standard — Label ↗AP
2010-09-14Labeling · Supplement 28 · unknown — Letter ↗AP
2007-01-16Labeling · Supplement 27 · standard — Label ↗AP
2005-09-28Labeling · Supplement 26 · standard — Label ↗AP
2005-02-17Labeling · Supplement 22 · standard — Letter ↗AP
2004-05-27Labeling · Supplement 24 · standard — Letter ↗AP
2004-05-27Labeling · Supplement 23 · standard — Letter ↗AP
2002-05-31Labeling · Supplement 19 · standard — Review ↗AP
2002-02-01Labeling · Supplement 17 · standard — Letter ↗AP
2002-02-01Labeling · Supplement 15 · standard — Letter ↗AP
2002-02-01Labeling · Supplement 13 — Letter ↗AP
2002-02-01Labeling · Supplement 11 — Letter ↗AP
2002-01-28Manufacturing (CMC) · Supplement 21AP
2001-03-26Manufacturing (CMC) · Supplement 20AP
1998-08-12Manufacturing (CMC) · Supplement 18AP
1995-08-08Labeling · Supplement 16 · standardAP
1992-05-12Labeling · Supplement 14AP
1991-04-10Manufacturing (CMC) · Supplement 12AP
1987-10-06Labeling · Supplement 8AP
1987-05-01Labeling · Supplement 7AP
1986-10-29Labeling · Supplement 5AP
1985-01-16Manufacturing (CMC) · Supplement 4AP
1983-03-01Manufacturing (CMC) · Supplement 1AP
1972-10-26UNKNOWN · Original · unknownAP
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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