APPLICATION
ANDA062500
TYPE
ANDA
ORIGINAL APPROVAL
1984-09-11
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 50MG BASE · CAPSULE · ORAL
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 100MG BASE · CAPSULE · ORAL
Approval history
2025-03-31Labeling · Supplement 58 · standardAP
2021-07-21Labeling · Supplement 56 · standardAP
2021-07-21Labeling · Supplement 54 · standardAP
2021-07-21Labeling · Supplement 52 · standardAP
2014-12-02Labeling · Supplement 45 · standardAP
2008-06-30Labeling · Supplement 42AP
2006-03-28Labeling · Supplement 38AP
2005-04-26Labeling · Supplement 30AP
2004-07-27Labeling · Supplement 29AP
2002-04-11Labeling · Supplement 25AP
2002-03-12Manufacturing (CMC) · Supplement 24AP
2001-09-12Manufacturing (CMC) · Supplement 23AP
2000-07-26Manufacturing (CMC) · Supplement 21AP
2000-07-26Labeling · Supplement 22AP
2000-01-28Manufacturing (CMC) · Supplement 20AP
1999-08-20Manufacturing (CMC) · Supplement 19AP
1999-07-23Manufacturing (CMC) · Supplement 17AP
1999-07-23Manufacturing (CMC) · Supplement 15AP
1999-07-23Manufacturing (CMC) · Supplement 18AP
1999-07-23Manufacturing (CMC) · Supplement 16AP
1999-07-23Manufacturing (CMC) · Supplement 14AP
1998-12-09Manufacturing (CMC) · Supplement 13AP
1997-05-30Manufacturing (CMC) · Supplement 12AP
1997-04-18Manufacturing (CMC) · Supplement 11AP
1997-04-18Manufacturing (CMC) · Supplement 10AP
1996-02-13Manufacturing (CMC) · Supplement 9AP
1994-01-13Labeling · Supplement 8AP
1993-06-22Manufacturing (CMC) · Supplement 6AP
1993-06-09Labeling · Supplement 7AP
1992-11-03Labeling · Supplement 5AP
1992-06-19Manufacturing (CMC) · Supplement 3AP
1992-06-19Manufacturing (CMC) · Supplement 4AP
1992-06-19Manufacturing (CMC) · Supplement 2AP
1991-08-22Labeling · Supplement 1AP
1984-09-11OriginalAP
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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