APPLICATION
ANDA063067
TYPE
ANDA
ORIGINAL APPROVAL
1990-07-31
LATEST ACTION
2026-03-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DYNACINDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE · CAPSULE · ORAL
DYNACINDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
DYNACINDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
Approval history
2026-03-24Labeling · Supplement 48 · standardAP
2026-03-24Labeling · Supplement 49 · standardAP
2026-03-24Labeling · Supplement 43 · standardAP
2014-12-23Labeling · Supplement 38 · standardAP
2003-08-04Labeling · Supplement 24AP
1999-12-02Manufacturing (CMC) · Supplement 12AP
1999-12-02Labeling · Supplement 13AP
1999-09-15Manufacturing (CMC) · Supplement 16AP
1999-09-15Manufacturing (CMC) · Supplement 14AP
1999-09-15Manufacturing (CMC) · Supplement 17AP
1999-09-15Labeling · Supplement 15AP
1999-06-24Manufacturing (CMC) · Supplement 11AP
1997-04-14Labeling · Supplement 10AP
1996-06-24Manufacturing (CMC) · Supplement 7AP
1996-06-24Manufacturing (CMC) · Supplement 8AP
1996-06-24Manufacturing (CMC) · Supplement 6AP
1996-04-24Labeling · Supplement 9AP
1994-11-07Labeling · Supplement 5AP
1993-12-21Manufacturing (CMC) · Supplement 4AP
1993-01-13Labeling · Supplement 3AP
1992-03-16Labeling · Supplement 2AP
1991-09-30Manufacturing (CMC) · Supplement 1AP
1990-07-31OriginalAP
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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