APPLICATION
ANDA065053
TYPE
ANDA
ORIGINAL APPROVAL
2000-11-22
LATEST ACTION
2026-01-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DOXYCYCLINEPrescription
DOXYCYCLINE EQ 75MG BASE · CAPSULE · ORAL
DOXYCYCLINEPrescription
DOXYCYCLINE EQ 50MG BASE · CAPSULE · ORAL
DOXYCYCLINEPrescription
DOXYCYCLINE EQ 100MG BASE · CAPSULE · ORAL
Approval history
2026-01-17Labeling · Supplement 34 · standardAP
2026-01-17Labeling · Supplement 26 · standardAP
2026-01-17Labeling · Supplement 35 · standardAP
2026-01-17Labeling · Supplement 31 · standardAP
2026-01-17Labeling · Supplement 23 · standardAP
2014-09-21Labeling · Supplement 18 · standardAP
2012-12-14Labeling · Supplement 17 · standardAP
2011-11-30Labeling · Supplement 15AP
2009-04-14Labeling · Supplement 14AP
2005-05-20Labeling · Supplement 9AP
2004-08-17Labeling · Supplement 7AP
2003-09-10Labeling · Supplement 5AP
2003-09-10Manufacturing (CMC) · Supplement 4AP
2003-04-30Labeling · Supplement 6AP
2002-12-23Labeling · Supplement 3AP
2001-12-13Manufacturing (CMC) · Supplement 1AP
2001-12-13Manufacturing (CMC) · Supplement 2AP
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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