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Drugs@FDA: FDA-Approved Drugs

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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.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-Container/Carton Labels, Labeling-Package Insert	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
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-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022466s001lbl.pdf
01/20/2011	SUPPL-1	Labeling-Package Insert	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

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