FDA ANDA · ANDA063011
MINOCYCLINE HYDROCHLORIDE
Sponsor: ZYDUS
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APPLICATION
ANDA063011
TYPE
ANDA
ORIGINAL APPROVAL
1992-03-02
LATEST ACTION
2026-10-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
Approval history
2026-10-19Labeling · Supplement 43 · standardAP
2026-10-19Labeling · Supplement 44 · standardAP
2020-04-20Labeling · Supplement 39 · standardAP
2020-04-20Labeling · Supplement 37 · standardAP
2020-04-20Labeling · Supplement 36 · standardAP
2013-06-17Labeling · Supplement 35 · standardAP
2010-12-13Labeling · Supplement 33AP
2008-01-30Labeling · Supplement 28AP
2001-06-07Manufacturing (CMC) · Supplement 23AP
2000-12-07Manufacturing (CMC) · Supplement 20AP
2000-12-07Manufacturing (CMC) · Supplement 21AP
2000-12-07Manufacturing (CMC) · Supplement 22AP
2000-10-31Manufacturing (CMC) · Supplement 19AP
2000-07-07Manufacturing (CMC) · Supplement 18AP
2000-03-15Manufacturing (CMC) · Supplement 17AP
1999-09-16Manufacturing (CMC) · Supplement 15AP
1999-09-16Manufacturing (CMC) · Supplement 13AP
1999-09-16Manufacturing (CMC) · Supplement 16AP
1999-09-16Manufacturing (CMC) · Supplement 14AP
1997-12-10Manufacturing (CMC) · Supplement 12AP
1997-06-18Manufacturing (CMC) · Supplement 11AP
1996-04-29Labeling · Supplement 10AP
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 4AP
1993-06-11Manufacturing (CMC) · Supplement 3AP
1992-04-17Manufacturing (CMC) · Supplement 1AP
1992-03-02OriginalAP
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