APPLICATION
ANDA062653
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-30
LATEST ACTION
2004-03-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
DORYXDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE · CAPSULE, DELAYED RELEASE · ORAL
Approval history
2004-03-26Labeling · Supplement 9AP
2003-11-10Labeling · Supplement 8AP
2000-05-11Manufacturing (CMC) · Supplement 5AP
2000-03-23Manufacturing (CMC) · Supplement 4AP
1998-02-06Manufacturing (CMC) · Supplement 3AP
1997-07-31Manufacturing (CMC) · Supplement 2AP
1985-10-30OriginalAP
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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