APPLICATION
ANDA062538
TYPE
ANDA
ORIGINAL APPROVAL
1986-04-07
LATEST ACTION
2026-02-06
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
2026-02-06Labeling · Supplement 22 · standardAP
2026-02-06Labeling · Supplement 21 · standardAP
2025-03-31Labeling · Supplement 19 · standardAP
2025-03-27Labeling · Supplement 14 · standardAP
2025-03-27Labeling · Supplement 17 · standardAP
2025-03-27Labeling · Supplement 13 · standardAP
1993-03-16Manufacturing (CMC) · Supplement 9AP
1991-02-23Manufacturing (CMC) · Supplement 8AP
1989-05-08Manufacturing (CMC) · Supplement 7AP
1986-04-07OriginalAP
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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