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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

SEPTOCAINE

NDANot in Orange Book

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | N022010 | DEPROCO

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 7, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4%;EQ 0.0085MG BASE/1.7ML (4%;EQ 0.005MG BASE/ML)

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INJECTABLE;INJECTION | Approved: Mar. 30, 2006

No patent or exclusivity listings for this strength.