APPLICATION
ANDA062269
TYPE
ANDA
ORIGINAL APPROVAL
1982-11-08
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 50MG BASE · TABLET · ORAL
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 100MG BASE · TABLET · ORAL
Approval history
2025-03-31Labeling · Supplement 51 · standardAP
2020-09-08Labeling · Supplement 29 · standardAP
2020-09-08Labeling · Supplement 43 · standardAP
2020-09-08Labeling · Supplement 41 · standardAP
2020-09-08Labeling · Supplement 31 · standardAP
2020-09-08Labeling · Supplement 38 · standardAP
2016-07-14Manufacturing (CMC) · Supplement 27 · unknownAP
2015-10-27Labeling · Supplement 28 · standardAP
2015-06-30Labeling · Supplement 24 · standardAP
2014-05-19Labeling · Supplement 22 · standardAP
2013-11-22Manufacturing (CMC) · Supplement 21 · unknownAP
2003-04-18Labeling · Supplement 18AP
2003-04-18Labeling · Supplement 20AP
2002-09-26Manufacturing (CMC) · Supplement 17AP
2002-07-24Manufacturing (CMC) · Supplement 15AP
2002-06-28Manufacturing (CMC) · Supplement 16AP
2002-02-08Manufacturing (CMC) · Supplement 14AP
2001-12-06Manufacturing (CMC) · Supplement 13AP
2001-11-02Manufacturing (CMC) · Supplement 7AP
2001-10-17Manufacturing (CMC) · Supplement 12AP
2001-10-17Manufacturing (CMC) · Supplement 10AP
2001-10-17Manufacturing (CMC) · Supplement 9AP
2001-10-17Manufacturing (CMC) · Supplement 11AP
2001-09-24Manufacturing (CMC) · Supplement 8AP
1997-11-12Manufacturing (CMC) · Supplement 6AP
1994-10-07Labeling · Supplement 5AP
1994-07-29Manufacturing (CMC) · Supplement 2AP
1993-08-31Labeling · Supplement 4AP
1993-08-31Labeling · Supplement 3AP
1992-11-05Manufacturing (CMC) · Supplement 1AP
1982-11-08OriginalAP
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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