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FDA ANDA · ANDA065156

MINOCYCLINE HYDROCHLORIDE

Sponsor: TORRENT

APPLICATION
ANDA065156
TYPE
ANDA
ORIGINAL APPROVAL
2004-01-06
LATEST ACTION
2020-04-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2020-04-06Labeling · Supplement 17 · standardAP
2020-04-06Labeling · Supplement 15 · standardAP
2012-05-11Labeling · Supplement 10ReviewAP
2008-10-27Labeling · Supplement 8AP
2004-06-23Labeling · Supplement 3AP
2004-01-06OriginalReviewAP
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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