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FDA ANDA · ANDA065005

MINOCYCLINE HYDROCHLORIDE

Sponsor: IMPAX LABS

APPLICATION
ANDA065005
TYPE
ANDA
ORIGINAL APPROVAL
1999-03-23
LATEST ACTION
2011-06-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2011-06-15Labeling · Supplement 11AP
2004-04-19Labeling · Supplement 8AP
2004-04-13Labeling · Supplement 7AP
2001-12-06Manufacturing (CMC) · Supplement 4AP
2001-04-18Labeling · Supplement 3AP
2001-04-18Manufacturing (CMC) · Supplement 1AP
2001-04-18Manufacturing (CMC) · Supplement 2AP
1999-03-23Original — Label ↗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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