APPLICATION
NDA050444
TYPE
NDA
ORIGINAL APPROVAL
1972-10-26
LATEST ACTION
2025-03-31
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MINOCIN · ReferencePrescription
MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2014-10-23Labeling · Supplement 48 · standardAP
2010-09-14Labeling · Supplement 47 · standardAP
2007-01-16Labeling · Supplement 45 · standardAP
2005-09-28Labeling · Supplement 44 · standardAP
2005-02-17Labeling · Supplement 38 · standardAP
2004-05-27Labeling · Supplement 43 · standardAP
2004-05-27Labeling · Supplement 42 · standardAP
2002-05-31Labeling · Supplement 36 · standardAP
2002-01-30Labeling · Supplement 29 · standardAP
2002-01-30Labeling · Supplement 33 · standardAP
2002-01-30Labeling · Supplement 34 · standardAP
1996-03-29Labeling · Supplement 31 · standardAP
1992-05-12Labeling · Supplement 9AP
1991-08-28Labeling · Supplement 8AP
1987-10-06Labeling · Supplement 4AP
1986-01-10Labeling · Supplement 2AP
1978-04-12Labeling · Supplement 27AP
1975-03-21Efficacy · Supplement 16AP
1974-11-04Labeling · Supplement 14AP
1973-10-04Labeling · Supplement 13AP
1972-10-26UNKNOWN · Original · unknownAP
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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