APPLICATION
ANDA091118
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-25
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued, None (Tentative Approval)
Products
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDENone (Tentative Approval)
MINOCYCLINE HYDROCHLORIDE EQ 55MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2025-03-31Labeling · Supplement 2 · standardAP
2019-12-03OriginalAP
2019-12-03OriginalTA
2014-09-25OriginalAP
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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