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FDA ANDA · ANDA203553

MINOCYCLINE HYDROCHLORIDE

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA203553
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-16
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

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 HYDROCHLORIDEDiscontinued
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 1 · standardAP
2023-06-16UNKNOWN · OriginalAP
2017-11-16UNKNOWN · OriginalLetterAP
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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