Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020774
Company: DEXCEL PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERIOCHIP CHLORHEXIDINE GLUCONATE 2.5MG TABLET;DENTAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/15/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20774lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20774ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20774.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/03/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/08/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020774s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020774Orig1s012ltr.pdf
01/12/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020774s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020774s011ltr.pdf
06/08/2011 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020774Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020774s010ltr.pdf
03/02/2004 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20774slr007_periochiop_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20774slr007ltr.pdf
02/21/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/22/2001 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/15/2002 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20774slr003_perioChip_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20774slr003ltr.pdf
06/29/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/05/1999 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/08/2012 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020774s012lbl.pdf
01/12/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020774s011lbl.pdf
06/08/2011 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020774Orig1s010lbl.pdf
03/02/2004 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20774slr007_periochiop_lbl.pdf
12/15/2002 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20774slr003_perioChip_lbl.pdf
05/15/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20774lbl.pdf

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