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FDA ANDA · ANDA065131

MINOCYCLINE HYDROCHLORIDE

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA065131
TYPE
ANDA
ORIGINAL APPROVAL
2003-04-16
LATEST ACTION
2012-05-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL

Approval history

2012-05-11Labeling · Supplement 17 — Label ↗AP
2010-01-19Labeling · Supplement 16AP
2008-06-30Labeling · Supplement 15AP
2005-03-17Labeling · Supplement 9AP
2004-01-05Labeling · Supplement 1AP
2003-04-16OriginalAP
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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