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FDA ANDA · ANDA204453

MINOCYCLINE HYDROCHLORIDE

Sponsor: ALKEM LABS LTD

APPLICATION
ANDA204453
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-28
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 55MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE · TABLET, EXTENDED RELEASE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-03-31Labeling · Supplement 8 · standardAP
2019-12-19UNKNOWN · OriginalAP
2018-03-16UNKNOWN · OriginalAP
2016-09-28UNKNOWN · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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