FDA NDA · NDA019028

PERIDEX

chlorhexidine gluconate

Sponsor: SOLVENTUM

APPLICATION

NDA019028

TYPE

NDA

ORIGINAL APPROVAL

1986-08-13

LATEST ACTION

2013-04-09

ROUTE

ORAL, DENTAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

PERIDEX · ReferencePrescription

CHLORHEXIDINE GLUCONATE 0.12% · SOLUTION · DENTAL

2013-04-09Manufacturing (CMC) · Supplement 21 · priorityAP

2013-01-16Manufacturing (CMC) · Supplement 22 · priority — Label ↗AP

2013-01-16Labeling · Supplement 20 · standard — Label ↗AP

2010-09-28Manufacturing (CMC) · Supplement 15 · priority — Letter ↗AP

2007-08-08Manufacturing (CMC) · Supplement 14AP

1999-06-07Manufacturing (CMC) · Supplement 11 · priorityAP

1999-06-07Manufacturing (CMC) · Supplement 12 · priorityAP

1997-11-21Manufacturing (CMC) · Supplement 10 · priorityAP

1997-01-08Labeling · Supplement 9 · standardAP

1997-01-08Labeling · Supplement 7 · standardAP

1997-01-08Labeling · Supplement 8 · standardAP

1992-12-04Manufacturing (CMC) · Supplement 6 · priorityAP

1992-08-20Manufacturing (CMC) · Supplement 5 · priorityAP

1991-01-25Manufacturing (CMC) · Supplement 4 · priorityAP

1988-03-31Labeling · Supplement 1AP

1986-08-13Type 3 - New Dosage Form · Original · priorityAP

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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