FDA NDA · NDA050751

ATRIDOX

Sponsor: DEN-MAT

APPLICATION

NDA050751

TYPE

NDA

ORIGINAL APPROVAL

1998-09-03

LATEST ACTION

2015-09-23

ROUTE

PERIODONTAL

DOSAGE FORM

SYSTEM, EXTENDED RELEASE

MARKETING STATUS

Discontinued

Products

ATRIDOX · ReferenceDiscontinued

DOXYCYCLINE HYCLATE 50MG · SYSTEM, EXTENDED RELEASE · PERIODONTAL

2015-09-23Manufacturing (CMC) · Supplement 20 · standardAP

2014-04-21Manufacturing (CMC) · Supplement 19 · standardAP

2011-02-14Labeling · Supplement 15 · unknown — Label ↗AP

2009-05-20Manufacturing (CMC) · Supplement 13 — Letter ↗AP

2003-06-20Manufacturing (CMC) · Supplement 11 · standard — Letter ↗AP

2003-03-16Labeling · Supplement 9 · standard — Label ↗AP

2000-02-25Manufacturing (CMC) · Supplement 5 · standardAP

1999-03-26Manufacturing (CMC) · Supplement 4 · standardAP

1999-03-11Manufacturing (CMC) · Supplement 3 · standardAP

1998-10-16Manufacturing (CMC) · Supplement 2 · standardAP

1998-10-02Manufacturing (CMC) · Supplement 1 · standardAP

1998-09-03Type 3 - New Dosage Form · Original · standard — Review ↗AP

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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