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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019028
Company: 3M

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERIDEX CHLORHEXIDINE GLUCONATE 0.12% SOLUTION;DENTAL Prescription AT 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
08/13/1986 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/16/2013 SUPPL-22 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s022lbl.pdf
04/09/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
01/16/2013 SUPPL-20 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019028Orig1s020ltr.pdf
09/28/2010 SUPPL-15 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019028s015ltr.pdf
08/08/2007 SUPPL-14 Labeling-Container/Carton Labels

Label is not available on this site.
06/07/1999 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
06/07/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
11/21/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
01/08/1997 SUPPL-9 Labeling

Label is not available on this site.
01/08/1997 SUPPL-8 Labeling

Label is not available on this site.
01/08/1997 SUPPL-7 Labeling

Label is not available on this site.
12/04/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
08/20/1992 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
01/25/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
03/31/1988 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/16/2013 SUPPL-22 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s022lbl.pdf
01/16/2013 SUPPL-20 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s020lbl.pdf

PERIDEX

SOLUTION;DENTAL; 0.12%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 0.12% SOLUTION;DENTAL Prescription No AT 075561 BAJAJ
CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 0.12% SOLUTION;DENTAL Prescription No AT 075006 CHARTWELL RX
CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 0.12% SOLUTION;DENTAL Prescription No AT 074291 LYNE
CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 0.12% SOLUTION;DENTAL Prescription No AT 074522 PHARM ASSOC
CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE 0.12% SOLUTION;DENTAL Prescription No AT 077789 XTTRIUM
PERIDEX CHLORHEXIDINE GLUCONATE 0.12% SOLUTION;DENTAL Prescription Yes AT 019028 3M
PERIOGARD CHLORHEXIDINE GLUCONATE 0.12% SOLUTION;DENTAL Prescription No AT 203212 COLGATE-PALMOLIVE CO
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