APPLICATION
ANDA062396
TYPE
ANDA
ORIGINAL APPROVAL
1984-11-07
LATEST ACTION
2026-01-20
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
2026-01-20Labeling · Supplement 90 · standardAP
2026-01-20Labeling · Supplement 91 · standardAP
2025-03-31Labeling · Supplement 89 · standardAP
2023-07-26Labeling · Supplement 57 · standardAP
2023-07-26Labeling · Supplement 55 · standardAP
2023-07-26Labeling · Supplement 61 · standardAP
2023-07-26Labeling · Supplement 74 · standardAP
2023-07-26Labeling · Supplement 58 · standardAP
2023-07-26Labeling · Supplement 72 · standardAP
2023-07-26Labeling · Supplement 56 · standardAP
2023-07-26Labeling · Supplement 54 · standardAP
2023-07-26Labeling · Supplement 60 · standardAP
2023-07-26Labeling · Supplement 77 · standardAP
2023-07-26Labeling · Supplement 59 · standardAP
2018-10-30Manufacturing (CMC) · Supplement 67 · unknownAP
2015-09-21Labeling · Supplement 49 · standardAP
2015-09-21Labeling · Supplement 53 · standardAP
2015-09-21Labeling · Supplement 51 · standardAP
2015-09-21Labeling · Supplement 48 · standardAP
2015-09-21Labeling · Supplement 52 · standardAP
2011-11-30Labeling · Supplement 44AP
2010-11-18Labeling · Supplement 42AP
2010-05-15Manufacturing (CMC) · Supplement 40AP
2008-06-30Labeling · Supplement 39AP
2007-05-31Labeling · Supplement 38AP
2006-05-08Labeling · Supplement 37AP
2004-10-04Labeling · Supplement 35AP
2003-10-24Labeling · Supplement 34AP
2002-12-09Manufacturing (CMC) · Supplement 33AP
2002-03-28Manufacturing (CMC) · Supplement 32AP
2001-06-22Manufacturing (CMC) · Supplement 31AP
2001-02-27Manufacturing (CMC) · Supplement 29AP
2001-01-25Manufacturing (CMC) · Supplement 30AP
2000-10-16Manufacturing (CMC) · Supplement 26AP
2000-09-11Manufacturing (CMC) · Supplement 27AP
2000-09-11Manufacturing (CMC) · Supplement 28AP
1999-11-08Manufacturing (CMC) · Supplement 25AP
1999-11-08Manufacturing (CMC) · Supplement 24AP
1998-10-01Manufacturing (CMC) · Supplement 23AP
1998-05-11Manufacturing (CMC) · Supplement 22AP
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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