FDA ANDA · ANDA063009
MINOCYCLINE HYDROCHLORIDE
Sponsor: ZYDUS
What this page does not claim
A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.
APPLICATION
ANDA063009
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 100MG BASE · CAPSULE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
Approval history
2026-10-19Labeling · Supplement 48 · standardAP
2026-10-19Labeling · Supplement 49 · standardAP
2020-04-20Labeling · Supplement 43 · standardAP
2020-04-20Labeling · Supplement 41 · standardAP
2020-04-20Labeling · Supplement 40 · standardAP
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
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →