01 23M Company
02 2DENTSPLY PHARM
03 4Galenica MA
04 4HANSAMED LIMITED
05 1Henry Schein
06 1Hospira, Inc.
07 2Novocol Pharmaceutical of Canada Inc
08 6Pierrel
09 7SEPTODONT INC
01 3INJ
02 8INJECTABLE;INJECTION
03 12SOLUTION
04 2Solution for injection
05 4Blank
01 3DISCN
02 12Ethical
03 1Generic
04 2Originator
05 4RX
06 7Blank
01 14% ASTRACAINE DENTAL WITH EPINEPHRINE 1:200,000 (0.005MG/ML)
02 14% ASTRACAINE DENTAL WITH EPINEPHRINE FORTE 1:100,000 (0.01MG/ML)
03 1ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
04 2ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION
05 2ORABLOC
06 1ORABLOC 1:100,000
07 1ORABLOC 1:200,000
08 1POSICAINE N
09 1POSICAINE SP
10 1SEPTANEST N
11 1SEPTANEST SP
12 3SEPTOCAINE
13 4Sarticain
14 1Septanest with Adrenaline 1/100,000
15 1Septocaine
16 1Septocaine Forte
17 1ULTACAN
18 1ULTACAN FORTE
19 1ULTRACAINE D-S FORTE INJECTION
20 1ULTRACAINE D-S INJECTION
21 1Ubistesin
22 1Ubistesin Forte
01 12Canada
02 4Italy
03 2Norway
04 3South Africa
05 8USA
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Ubistesin
Dosage Form : INJ
Dosage Strength : 40mg/ml
Packaging : 50X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Ubistesin Forte
Dosage Form : INJ
Dosage Strength : 40mg/ml
Packaging : 50X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : 4% ASTRACAINE DENTAL WITH EPINEPHRINE FORTE 1:100,000 (0.01MG/ML)
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 1.8ML
Approval Date :
Application Number : 2248488
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : 4% ASTRACAINE DENTAL WITH EPINEPHRINE 1:200,000 (0.005MG/ML)
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 1.8ML
Approval Date :
Application Number : 2248489
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info :
Registration Country : Italy
ARTICAINE HYDROCHLORIDE; Adrenaline Bitartrate
Brand Name : Sarticain
Dosage Form :
Dosage Strength : 10 Vials 20 Ml With Adrenaline 1:100,000
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
ARTICAINE HYDROCHLORIDE; Adrenaline Bitartrate
Brand Name : Sarticain
Dosage Form :
Dosage Strength : 10 Vials 20 Ml With Adrenaline 1:200,000
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
ARTICAINE HYDROCHLORIDE; Adrenaline Bitartrate
Brand Name : Sarticain
Dosage Form :
Dosage Strength : 60 Tubofiale 1.7 Ml With Adrenaline 1:200,000
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
ARTICAINE HYDROCHLORIDE; Adrenaline Bitartrate
Brand Name : Sarticain
Dosage Form :
Dosage Strength : 60 Tubofiale 1.7 Ml With Adrenaline 1:100,000
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : DISCN
Registration Country : USA
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)
Packaging :
Approval Date : 2017-07-11
Application Number : 201750
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
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)
Packaging :
Approval Date : 2017-07-11
Application Number : 201751
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : ULTRACAINE D-S INJECTION
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 1.7ML
Approval Date :
Application Number : 1988530
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : ULTRACAINE D-S FORTE INJECTION
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 1.7 ML
Approval Date :
Application Number : 1988557
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Septanest with Adrenaline 1/100,000
Dosage Form : INJ
Dosage Strength : 68mg/1.7ml
Packaging : 1.7X50mg/1.7ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : DISCN
Registration Country : USA
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)
Packaging :
Approval Date : 2010-06-18
Application Number : 79138
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : POSICAINE SP
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 50X1.7ML
Approval Date :
Application Number : 2381338
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : POSICAINE N
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 50X1.7ML
Approval Date :
Application Number : 2381311
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
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)
Packaging :
Approval Date : 2010-02-26
Application Number : 22466
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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)
Packaging :
Approval Date : 2010-02-26
Application Number : 22466
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : ORABLOC 1:200,000
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 1.7ML
Approval Date :
Application Number : 2361906
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : ORABLOC 1:100,000
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 1.7ML
Approval Date :
Application Number : 2361914
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 50X1.7ML
Approval Date :
Application Number : 2339536
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 50X1.7ML
Approval Date :
Application Number : 2339544
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
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)
Packaging :
Approval Date : 2000-04-03
Application Number : 20971
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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)
Packaging :
Approval Date : 2006-03-30
Application Number : 20971
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
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)
Packaging :
Approval Date :
Application Number : 22010
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Artikainhydrochloride; Adrenalintratrait
Brand Name : Septocaine
Dosage Form : Solution for injection
Dosage Strength : 40 mg/ml/5 microg/ml
Packaging : Glass cylinders 50 1.7ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Artikainhydrochloride; Adrenalintratrait
Brand Name : Septocaine Forte
Dosage Form : Solution for injection
Dosage Strength : 40 mg/ml/10 microg/ml
Packaging : Glass cylinders 50 1.7ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : SEPTANEST N
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 50X1.7ML
Approval Date :
Application Number : 2123371
Regulatory Info : Ethical
Registration Country : Canada
Regulatory Info : Ethical
Registration Country : Canada
Brand Name : SEPTANEST SP
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 50X1.7ML
Approval Date :
Application Number : 2123398
Regulatory Info : Ethical
Registration Country : Canada
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