APPLICATION
ANDA090134
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-14
LATEST ACTION
2024-04-12
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 200MG BASE · TABLET, DELAYED RELEASE · ORAL
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 100MG BASE · TABLET, DELAYED RELEASE · ORAL
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 50MG BASE · TABLET, DELAYED RELEASE · ORAL
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 75MG BASE · TABLET, DELAYED RELEASE · ORAL
Approval history
2024-04-12Labeling · Supplement 23 · standardAP
2024-04-12Labeling · Supplement 26 · standardAP
2021-01-13Labeling · Supplement 21 · standardAP
2017-12-27Labeling · Supplement 17 · standardAP
2017-12-27Labeling · Supplement 15 · standardAP
2017-12-27Labeling · Supplement 14 · standardAP
2014-04-22Labeling · Supplement 11 · standardAP
2011-12-14OriginalAP
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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