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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020774
Company: DEXCEL PHARMA

Products on NDA 020774

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERIOCHIP	CHLORHEXIDINE GLUCONATE	2.5MG	TABLET;DENTAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020774

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.

Labels for NDA 020774

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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