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FDA ANDA · ANDA065485

MINOCYCLINE HYDROCHLORIDE

Sponsor: BARR LABS INC

APPLICATION
ANDA065485
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-17
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-03-31Labeling · Supplement 17 · standardAP
2019-06-28Labeling · Supplement 11 · standardAP
2017-04-26Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2017-04-26Manufacturing (CMC) · Supplement 8 — Letter ↗AP
2014-11-26Labeling · Supplement 7 · standardAP
2012-05-18UNKNOWN · Supplement 4 · standard — Letter ↗AP
2011-11-14Labeling · Supplement 6AP
2009-03-17OriginalAP
VIEW ON DRUGS@FDA ↗

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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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