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FDA ANDA · ANDA090911

MINOCYCLINE HYDROCHLORIDE

Sponsor: PHARMOBEDIENT

APPLICATION
ANDA090911
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-20
LATEST ACTION
2016-04-19
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

MINOCYCLINE HYDROCHLORIDEDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 90MG 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

Approval history

2016-04-19Labeling · Supplement 3 · standardAP
2012-06-05Labeling · Supplement 2AP
2010-07-20OriginalLabelAP
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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