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FDA NDA · NDA050582

DORYX

Sponsor: MAYNE PHARMA

APPLICATION
NDA050582
TYPE
NDA
ORIGINAL APPROVAL
1985-07-22
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

DORYX · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE · CAPSULE, DELAYED RELEASE · ORAL
DORYX · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 75MG BASE · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2025-03-31Labeling · Supplement 32 · standard — Label ↗AP
2020-03-02Labeling · Supplement 31 · standard — Letter ↗AP
2018-02-07Labeling · Supplement 30 · standard — Label ↗AP
2015-09-02Labeling · Supplement 29 · standard — Label ↗AP
2011-03-21Labeling · Supplement 28 · standard — Letter ↗AP
2008-02-07Labeling · Supplement 27 · standard — Label ↗AP
2005-05-06Labeling · Supplement 24 · standard — Label ↗AP
2004-02-13Labeling · Supplement 22 · standard — Letter ↗AP
2003-06-05Labeling · Supplement 21 · standard — Letter ↗AP
2002-10-25Manufacturing (CMC) · Supplement 18 · standardAP
2002-06-18Labeling · Supplement 16 · standard — Letter ↗AP
2002-05-22Manufacturing (CMC) · Supplement 17 · standardAP
2001-08-13Manufacturing (CMC) · Supplement 15 · standardAP
2001-05-04Manufacturing (CMC) · Supplement 14 · standardAP
2001-03-15Manufacturing (CMC) · Supplement 13 · standardAP
1999-09-01Manufacturing (CMC) · Supplement 12 · standardAP
1993-03-29Manufacturing (CMC) · Supplement 11 · standardAP
1991-08-26Manufacturing (CMC) · Supplement 10 · standardAP
1991-08-26Manufacturing (CMC) · Supplement 9 · standardAP
1986-05-30Manufacturing (CMC) · Supplement 8 · standardAP
1985-10-02Manufacturing (CMC) · Supplement 7 · standardAP
1985-09-17Manufacturing (CMC) · Supplement 6 · standardAP
1985-09-17Manufacturing (CMC) · Supplement 4 · standardAP
1985-09-17Labeling · Supplement 2AP
1985-09-12Manufacturing (CMC) · Supplement 3 · standardAP
1985-07-22Type 3 - New Dosage Form · Original · standardAP
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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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