APPLICATION
ANDA062337
TYPE
ANDA
ORIGINAL APPROVAL
1982-03-29
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 100MG BASE · CAPSULE · ORAL
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 50MG BASE · CAPSULE · ORAL
Approval history
2025-03-31Labeling · Supplement 39 · standardAP
2025-03-25Labeling · Supplement 35 · standardAP
2025-03-25Labeling · Supplement 27 · standardAP
2025-03-25Labeling · Supplement 33 · standardAP
2025-03-25Labeling · Supplement 31 · standardAP
2025-03-25Labeling · Supplement 38 · standardAP
2025-03-25Labeling · Supplement 30 · standardAP
2015-06-30Labeling · Supplement 25 · standardAP
2014-09-02Labeling · Supplement 24 · standardAP
2002-12-23Labeling · Supplement 23AP
1998-02-25Manufacturing (CMC) · Supplement 21AP
1998-02-05Manufacturing (CMC) · Supplement 22AP
1993-10-22Manufacturing (CMC) · Supplement 19AP
1993-10-22Manufacturing (CMC) · Supplement 20AP
1993-06-01Labeling · Supplement 17AP
1992-12-16Labeling · Supplement 16AP
1992-05-12Labeling · Supplement 15AP
1992-05-12Labeling · Supplement 14AP
1990-01-31Manufacturing (CMC) · Supplement 13AP
1990-01-31Manufacturing (CMC) · Supplement 12AP
1989-04-25Manufacturing (CMC) · Supplement 11AP
1982-03-29OriginalAP
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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