APPLICATION
ANDA062497
TYPE
ANDA
ORIGINAL APPROVAL
1984-08-23
LATEST ACTION
2014-05-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DOXY-LEMMONDiscontinued
DOXYCYCLINE HYCLATE EQ 50MG BASE · CAPSULE · ORAL
DOXY-LEMMONDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE · CAPSULE · ORAL
Approval history
2014-05-19Labeling · Supplement 24 · standardAP
2001-08-30Manufacturing (CMC) · Supplement 23AP
1994-06-23Manufacturing (CMC) · Supplement 19AP
1994-06-23Manufacturing (CMC) · Supplement 17AP
1994-06-23Manufacturing (CMC) · Supplement 18AP
1994-01-26Manufacturing (CMC) · Supplement 21AP
1994-01-26Manufacturing (CMC) · Supplement 22AP
1994-01-26Manufacturing (CMC) · Supplement 20AP
1993-04-01Manufacturing (CMC) · Supplement 16AP
1992-03-26Labeling · Supplement 14AP
1990-10-03Manufacturing (CMC) · Supplement 13AP
1988-05-03Manufacturing (CMC) · Supplement 12AP
1987-11-09Manufacturing (CMC) · Supplement 11AP
1984-08-23OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.