APPLICATION
ANDA062031
TYPE
ANDA
ORIGINAL APPROVAL
1982-10-13
LATEST ACTION
2025-03-31
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
2025-03-31Labeling · Supplement 85 · standardAP
2021-05-17Labeling · Supplement 81 · standardAP
2021-05-17Labeling · Supplement 82 · standardAP
2018-01-02Labeling · Supplement 80 · standardAP
2018-01-02Labeling · Supplement 79 · standardAP
2014-04-30Labeling · Supplement 74 · standardAP
2010-07-28Labeling · Supplement 63AP
2005-09-01Labeling · Supplement 43AP
2002-12-23Labeling · Supplement 39AP
2002-02-20Labeling · Supplement 38AP
2001-04-25Manufacturing (CMC) · Supplement 37AP
2001-02-08Manufacturing (CMC) · Supplement 36AP
2000-08-09Labeling · Supplement 35AP
1999-06-16Manufacturing (CMC) · Supplement 34AP
1998-10-23Manufacturing (CMC) · Supplement 32AP
1998-08-10Manufacturing (CMC) · Supplement 29AP
1998-08-10Manufacturing (CMC) · Supplement 31AP
1998-08-10Manufacturing (CMC) · Supplement 30AP
1993-09-01Labeling · Supplement 28AP
1993-04-14Labeling · Supplement 27AP
1992-10-23Labeling · Supplement 26AP
1992-02-26Labeling · Supplement 25AP
1991-05-31Manufacturing (CMC) · Supplement 20AP
1991-05-31Manufacturing (CMC) · Supplement 23AP
1990-11-15Manufacturing (CMC) · Supplement 21AP
1990-11-15Manufacturing (CMC) · Supplement 24AP
1988-05-16Manufacturing (CMC) · Supplement 16AP
1982-10-13OriginalAP
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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