APPLICATION
ANDA090422
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-13
LATEST ACTION
2025-03-31
ROUTE
Oral, ORAL
DOSAGE FORM
Tablet, Extended Release, TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval), Prescription
Products
MINOCYCLINE HYDROCHLORIDENone (Tentative Approval)
MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE · Tablet, Extended Release · Oral
MINOCYCLINE HYDROCHLORIDENone (Tentative Approval)
MINOCYCLINE HYDROCHLORIDE EQ 55MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDENone (Tentative Approval)
MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDENone (Tentative Approval)
MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE · Tablet, Extended Release · Oral
MINOCYCLINE HYDROCHLORIDENone (Tentative Approval)
MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-03-31Labeling · Supplement 16 · standardAP
2015-08-26Labeling · Supplement 11 · standardAP
2013-07-02Labeling · Supplement 8AP
2012-12-21Manufacturing (CMC) · Supplement 6 · unknownTA
2011-01-21Labeling · Supplement 3AP
2009-08-13OriginalAP
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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