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FDA ANDA · ANDA063009

MINOCYCLINE HYDROCHLORIDE

Sponsor: ZYDUS

APPLICATION
ANDA063009
TYPE
ANDA
ORIGINAL APPROVAL
1992-03-02
LATEST ACTION
2020-04-20
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

Approval history

2020-04-20Labeling · Supplement 43 · standardAP
2020-04-20Labeling · Supplement 41 · standardAP
2020-04-20Labeling · Supplement 40 · standardAP
2013-01-02Labeling · Supplement 34 — Letter ↗AP
2010-12-13Labeling · Supplement 38AP
2008-01-30Labeling · Supplement 31AP
2003-08-13Manufacturing (CMC) · Supplement 24AP
2003-08-12Labeling · Supplement 25AP
2001-06-07Manufacturing (CMC) · Supplement 23AP
2000-12-07Manufacturing (CMC) · Supplement 21AP
2000-12-07Manufacturing (CMC) · Supplement 22AP
2000-12-07Manufacturing (CMC) · Supplement 20AP
2000-10-26Manufacturing (CMC) · Supplement 19AP
2000-07-07Manufacturing (CMC) · Supplement 18AP
2000-03-15Manufacturing (CMC) · Supplement 17AP
2000-03-15Manufacturing (CMC) · Supplement 16AP
1999-09-20Manufacturing (CMC) · Supplement 15AP
1999-09-20Manufacturing (CMC) · Supplement 13AP
1999-09-20Manufacturing (CMC) · Supplement 14AP
1999-09-20Manufacturing (CMC) · Supplement 12AP
1997-12-10Manufacturing (CMC) · Supplement 11AP
1997-06-18Manufacturing (CMC) · Supplement 10AP
1996-04-29Labeling · Supplement 9AP
1995-02-16Manufacturing (CMC) · Supplement 8AP
1994-09-06Manufacturing (CMC) · Supplement 7AP
1994-03-31Labeling · Supplement 6AP
1993-11-02Manufacturing (CMC) · Supplement 2AP
1993-10-06Labeling · Supplement 5AP
1993-06-11Manufacturing (CMC) · Supplement 3AP
1993-06-11Manufacturing (CMC) · Supplement 4AP
1992-04-17Manufacturing (CMC) · Supplement 1AP
1992-03-02OriginalAP
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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