APPLICATION
ANDA062505
TYPE
ANDA
ORIGINAL APPROVAL
1984-09-11
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 100MG BASE · TABLET · ORAL
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 50MG BASE · TABLET · ORAL
Approval history
2025-03-31Labeling · Supplement 84 · standardAP
2021-07-27Manufacturing (CMC) · Supplement 81 · unknownAP
2021-07-21Labeling · Supplement 78 · standardAP
2021-07-21Labeling · Supplement 80 · standardAP
2021-07-21Labeling · Supplement 77 · standardAP
2014-12-02Labeling · Supplement 70 · standardAP
2012-04-25Labeling · Supplement 68AP
2008-06-30Labeling · Supplement 59AP
2006-03-28Labeling · Supplement 56AP
2005-04-26Labeling · Supplement 39AP
2004-07-27Labeling · Supplement 37AP
2002-12-09Manufacturing (CMC) · Supplement 34AP
2002-04-11Labeling · Supplement 33AP
2002-03-20Manufacturing (CMC) · Supplement 29AP
2002-03-20Manufacturing (CMC) · Supplement 31AP
2002-03-20Manufacturing (CMC) · Supplement 30AP
2001-12-21Manufacturing (CMC) · Supplement 32AP
2001-09-12Manufacturing (CMC) · Supplement 27AP
2000-07-26Manufacturing (CMC) · Supplement 25AP
2000-07-26Labeling · Supplement 26AP
2000-01-28Manufacturing (CMC) · Supplement 24AP
1999-08-20Manufacturing (CMC) · Supplement 23AP
1999-07-08Manufacturing (CMC) · Supplement 19AP
1999-07-08Manufacturing (CMC) · Supplement 21AP
1999-07-08Manufacturing (CMC) · Supplement 18AP
1999-07-08Manufacturing (CMC) · Supplement 22AP
1999-07-08Manufacturing (CMC) · Supplement 20AP
1998-12-09Manufacturing (CMC) · Supplement 17AP
1998-09-04Manufacturing (CMC) · Supplement 16AP
1997-12-22Manufacturing (CMC) · Supplement 15AP
1997-05-30Manufacturing (CMC) · Supplement 14AP
1995-09-27Manufacturing (CMC) · Supplement 13AP
1994-01-13Labeling · Supplement 12AP
1993-06-09Labeling · Supplement 11AP
1992-11-06Labeling · Supplement 10AP
1992-09-03Manufacturing (CMC) · Supplement 9AP
1992-09-03Manufacturing (CMC) · Supplement 8AP
1992-05-01Labeling · Supplement 7AP
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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