An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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.cfm

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

Top