APPLICATION
ANDA065070
TYPE
ANDA
ORIGINAL APPROVAL
2000-12-15
LATEST ACTION
2026-03-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DOXYCYCLINEPrescription
DOXYCYCLINE EQ 75MG BASE · TABLET · ORAL
DOXYCYCLINEPrescription
DOXYCYCLINE EQ 50MG BASE · TABLET · ORAL
DOXYCYCLINEPrescription
DOXYCYCLINE EQ 150MG BASE · TABLET · ORAL
DOXYCYCLINEPrescription
DOXYCYCLINE EQ 100MG BASE · TABLET · ORAL
Approval history
2026-03-20Labeling · Supplement 35 · standardAP
2024-08-26Labeling · Supplement 32 · standardAP
2022-08-30Labeling · Supplement 28 · standardAP
2022-08-30Labeling · Supplement 27 · standardAP
2017-10-30Labeling · Supplement 25 · standardAP
2015-12-20Labeling · Supplement 17AP
2015-12-20Labeling · Supplement 21 · standardAP
2013-05-31Labeling · Supplement 18AP
2009-03-12Labeling · Supplement 16AP
2005-07-14Supplement · Supplement 9AP
2005-07-14Labeling · Supplement 10AP
2004-03-26Labeling · Supplement 8AP
2003-05-21Labeling · Supplement 7AP
2002-12-30Manufacturing (CMC) · Supplement 5AP
2002-12-30Labeling · Supplement 6AP
2002-02-26Labeling · Supplement 2AP
2001-10-17Manufacturing (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.
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.