APPLICATION
ANDA063065
TYPE
ANDA
ORIGINAL APPROVAL
1991-12-30
LATEST ACTION
2026-05-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
MINOCYCLINE HYDROCHLORIDEPrescription
MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE · CAPSULE · ORAL
Approval history
2026-05-12Labeling · Supplement 64 · standardAP
2026-05-12Labeling · Supplement 63 · standardAP
2020-05-05Labeling · Supplement 58 · standardAP
2020-05-05Labeling · Supplement 56 · standardAP
2020-05-05Labeling · Supplement 59 · standardAP
2008-11-20Labeling · Supplement 44AP
2008-04-25Labeling · Supplement 40AP
2001-10-22Labeling · Supplement 20AP
2001-10-22Manufacturing (CMC) · Supplement 19AP
2001-04-25Manufacturing (CMC) · Supplement 18AP
1999-06-02Manufacturing (CMC) · Supplement 17AP
1998-12-09Manufacturing (CMC) · Supplement 13AP
1998-05-12Manufacturing (CMC) · Supplement 9AP
1998-05-12Manufacturing (CMC) · Supplement 8AP
1998-04-07Manufacturing (CMC) · Supplement 11AP
1998-04-07Manufacturing (CMC) · Supplement 12AP
1998-04-07Manufacturing (CMC) · Supplement 10AP
1997-11-05Manufacturing (CMC) · Supplement 7AP
1996-05-08Labeling · Supplement 5AP
1996-03-04Labeling · Supplement 3AP
1996-03-04Labeling · Supplement 65AP
1992-07-22Manufacturing (CMC) · Supplement 1AP
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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