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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021451
Company: DENTSPLY PHARM

Products on NDA 021451

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORAQIX	LIDOCAINE; PRILOCAINE	2.5%;2.5%	GEL;PERIODONTAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021451

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2003	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21451_oraqix_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21451ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021451s000_OraqixTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2018	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021451s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021451Orig1s014ltr.pdf
03/02/2022	SUPPL-13	Labeling-Container/Carton Labels		Label is not available on this site.
08/08/2012	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021451s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021451Orig1s008ltr.pdf
09/27/2010	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021451s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021451s007ltr.pdf
04/13/2010	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021451s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021451s005ltr.pdf

Labels for NDA 021451

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2018	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021451s014lbl.pdf
08/08/2012	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021451s008lbl.pdf
09/27/2010	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021451s007lbl.pdf
04/13/2010	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021451s005lbl.pdf
12/19/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21451_oraqix_lbl.pdf

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