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Approved Drug Products containing Articaine Hydrochloride listed in the FDA Orange Book. Original Data : FDA Website

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01 3DEPROCO

02 2HANSAMED INC

03 1HOSPIRA

04 2PIERREL

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PharmaCompass

01

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Brand Name : ULTACAN FORTE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML)

Approval Date : 2017-07-11

Application Number : 201750

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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02

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Brand Name : ULTACAN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4%;EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)

Approval Date : 2017-07-11

Application Number : 201751

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Brand Name : ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)

Approval Date : 2010-06-18

Application Number : 79138

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Brand Name : ORABLOC

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML)

Approval Date : 2010-02-26

Application Number : 22466

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Brand Name : ORABLOC

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML)

Approval Date : 2010-02-26

Application Number : 22466

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Brand Name : SEPTOCAINE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)

Approval Date : 2000-04-03

Application Number : 20971

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Brand Name : SEPTOCAINE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)

Approval Date : 2006-03-30

Application Number : 20971

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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08

26th North American ISSX
Not Confirmed
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26th North American ISSX
Not Confirmed

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Brand Name : SEPTOCAINE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4%;EQ 0.0085MG BASE/1.7ML (4%;EQ 0.005MG BASE/ML)

Approval Date :

Application Number : 22010

RX/OTC/DISCN :

RLD :

TE Code :

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