Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019028
Company: SOLVENTUM

Products on NDA 19028

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

Labels for NDA 019028

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