APPLICATION
ANDA065062
TYPE
ANDA
ORIGINAL APPROVAL
2000-11-30
LATEST ACTION
2025-10-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE · CAPSULE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
Approval history
2025-10-10Labeling · Supplement 31 · standardAP
2025-03-06Labeling · Supplement 24 · standardAP
2025-03-06Labeling · Supplement 30 · standardAP
2025-03-06Labeling · Supplement 22 · standardAP
2014-05-14Labeling · Supplement 21 · standardAP
2011-05-23Labeling · Supplement 16AP
2008-11-06Labeling · Supplement 12AP
2004-03-31Labeling · Supplement 5AP
2002-02-14Manufacturing (CMC) · Supplement 2AP
2002-02-14Manufacturing (CMC) · Supplement 1AP
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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