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FDA ANDA · ANDA090024

MINOCYCLINE HYDROCHLORIDE

Sponsor: IMPAX LABS INC

APPLICATION
ANDA090024
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-03
LATEST ACTION
2025-03-31
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

2025-03-31Labeling · Supplement 10 · standardAP
2013-05-31Labeling · Supplement 6AP
2011-10-31Labeling · Supplement 2AP
2010-05-13Labeling · Supplement 1AP
2009-02-03OriginalLetterAP
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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