Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022466
Company: PIERREL
Company: PIERREL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ORABLOC | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) | INJECTABLE;INJECTION | Prescription | None | Yes | No |
ORABLOC | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
02/26/2010 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022466lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022466s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022466_articaine_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022466Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/02/2018 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022466s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022466Orig1s005ltr.pdf | |
03/10/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/20/2011 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022466s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022466s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/02/2018 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022466s005lbl.pdf | |
01/20/2011 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022466s001lbl.pdf | |
01/20/2011 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022466s001lbl.pdf | |
02/26/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022466lbl.pdf |