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): 022466
Company: PIERREL

Summary Review

Products on NDA 022466

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022466

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.html 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
07/02/2025	SUPPL-9	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022466s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022466Orig1s009ltr.pdf
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

Labels for NDA 022466

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/02/2025	SUPPL-9	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022466s009lbl.pdf
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

Top