Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021451
Company: DENTSPLY PHARM
Company: DENTSPLY PHARM
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 |
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 |
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 |