FDA NDA · NDA020774

PERIOCHIP

Sponsor: DEXCEL PHARMA

APPLICATION

NDA020774

TYPE

NDA

ORIGINAL APPROVAL

1998-05-15

LATEST ACTION

2013-07-03

ROUTE

DENTAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

PERIOCHIP · ReferenceDiscontinued

CHLORHEXIDINE GLUCONATE 2.5MG · TABLET · DENTAL

2013-07-03Manufacturing (CMC) · Supplement 13 · standardAP

2012-11-08Labeling · Supplement 12 · standard — Label ↗AP

2012-01-12Labeling · Supplement 11 · standard — Letter ↗AP

2011-06-08Labeling · Supplement 10 · unknown — Label ↗AP

2004-03-02Labeling · Supplement 7 · standard — Letter ↗AP

2002-12-15Labeling · Supplement 3 · standard — Letter ↗AP

2002-02-21Manufacturing (CMC) · Supplement 5 · standardAP

2001-03-22Manufacturing (CMC) · Supplement 4 · standardAP

1999-06-29Manufacturing (CMC) · Supplement 2 · standardAP

1999-04-05Manufacturing (CMC) · Supplement 1 · standardAP

1998-05-15Type 3 - New Dosage Form · Original · standard — Label ↗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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