APPLICATION
ANDA065470
TYPE
ANDA
ORIGINAL APPROVAL
2008-03-11
LATEST ACTION
2025-02-04
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
2025-02-04Labeling · Supplement 16 · standardAP
2020-04-19Labeling · Supplement 10 · standardAP
2020-04-19Labeling · Supplement 8 · standardAP
2020-04-19Labeling · Supplement 11 · standardAP
2020-04-19Labeling · Supplement 7 · standardAP
2014-08-11Labeling · Supplement 6 · standardAP
2011-10-31Labeling · Supplement 3AP
2008-09-22Labeling · Supplement 1AP
2008-03-11OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.