APPLICATION
ANDA061717
TYPE
ANDA
ORIGINAL APPROVAL
1973-07-17
LATEST ACTION
2003-08-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DOXYCYCLINE HYCLATEDiscontinued
DOXYCYCLINE HYCLATE EQ 50MG BASE · CAPSULE · ORAL
DOXYCYCLINE HYCLATEDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE · CAPSULE · ORAL
Approval history
2003-08-29Labeling · Supplement 29AP
2002-09-03Manufacturing (CMC) · Supplement 27AP
2002-07-24Manufacturing (CMC) · Supplement 25AP
2002-06-18Manufacturing (CMC) · Supplement 26AP
2002-03-14Manufacturing (CMC) · Supplement 24AP
2002-02-08Manufacturing (CMC) · Supplement 21AP
2001-12-06Manufacturing (CMC) · Supplement 22AP
2001-11-02Manufacturing (CMC) · Supplement 15AP
2001-10-17Manufacturing (CMC) · Supplement 19AP
2001-10-17Manufacturing (CMC) · Supplement 17AP
2001-10-17Manufacturing (CMC) · Supplement 18AP
2001-10-17Manufacturing (CMC) · Supplement 20AP
2001-09-24Manufacturing (CMC) · Supplement 16AP
1997-12-09Manufacturing (CMC) · Supplement 13AP
1997-12-09Manufacturing (CMC) · Supplement 14AP
1994-10-07Labeling · Supplement 12AP
1994-01-11Labeling · Supplement 11AP
1992-03-18Manufacturing (CMC) · Supplement 9AP
1991-07-23Labeling · Supplement 10AP
1991-02-04Manufacturing (CMC) · Supplement 8AP
1989-05-17Bioequivalence · Supplement 1AP
1988-08-31Manufacturing (CMC) · Supplement 6AP
1987-07-29Manufacturing (CMC) · Supplement 3AP
1987-07-08Manufacturing (CMC) · Supplement 2AP
1973-07-17OriginalAP
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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