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DENTSPLY PHARM
FDF Dossiers

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2024-10-07

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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DENTSPLY PHARM

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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 32 NEWS #PharmaBuzz

INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
32 NEWS #PharmaBuzz

FINISHED DOSAGE FORMULATIONS

35 FDF Dossiers, 9 FDA Orange Book, 12 Europe, 14 Canada

35 FDF Dossiers
9 FDA Orange Book
12 Europe
14 Canada

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filter Active Ingredients Reset all filters

35 All

01 2ARTICAINE HYDROCHLORIDE

02 2EPINEPHRINE

03 3EPINEPHRINE (EPINEPHRINE BITARTRATE)

04 1EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

05 1EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

06 2EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

07 1Flera substanser, se innehåll

08 1LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

09 1LIDOCAINE

10 3LIDOCAINE HYDROCHLORIDE

11 1LIDOCAINE; PRILOCAINE

12 2Lidocaine

13 1Lidocaine; Prilocaine

14 2MEPIVACAINE HYDROCHLORIDE

15 2Mepivacaine

16 1Mepivacaine hydrochloride

17 1PRILOCAINE

18 3PRILOCAINE HYDROCHLORIDE

19 2Prilocaine

20 2Several substances refer to content

21 1mepivacaine

filter Applicant Reset all filters

35 All

01 14DENTSPLY CANADA LIMITED

02 1DENTSPLY ITALIA Srl

03 9DENTSPLY PHARM

04 1Dentsply DeTrey GmbH

05 2Dentsply Limited

06 4Dentsply Limited,

07 4Dentsply Ltd

filter Dosage Form Reset all filters

35 All

01 2GEL

02 1GEL;PERIODONTAL

03 8INJECTABLE;INJECTION

04 6Injection fluid, resolution

05 1LIQUID

06 1PERIODONTALGEL

07 11SOLUTION

08 3SOLUTION FOR INJECTION

09 1Solution for injection

10 1Blank

filter Dosage Reset all filters

35 All

01 1--

02 20.005MG/ML

03 10.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

04 10.005MG/ML;4%

05 20.01MG/ML

06 10.01MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

07 10.02MG/ML

08 10.02MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

09 10.05MG/ML;2%

10 12%

11 22.5%

12 12.5%;2.5%

13 120 MG / ML + 12

14 220 mg/ml/12.5 mcg/ml

15 220MG/ML

16 13%

17 130 MG / ML

18 130 MG / ML + 0

19 330 mg/ml

20 230 mg/ml/0.03 IE/ml

21 130MG/ML

22 14%

23 440MG/ML

24 1Periodontal Gels 20 Cart 1.7 G 25 Mg/G + 25 Mg/G

filter Country Reset all filters

35 All

01 14Canada

02 1Italy

03 7Norway

04 4Sweden

05 9USA

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01

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Ethical

Registration Country : Canada

ARTICAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : 4% ASTRACAINE DENTAL WITH...

Dosage Strength : 40MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2248488

Regulatory Info : Ethical

Registration Country : Canada

Product
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02

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Ethical

Registration Country : Canada

ARTICAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : 4% ASTRACAINE DENTAL WITH...

Dosage Strength : 40MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2248489

Regulatory Info : Ethical

Registration Country : Canada

Product
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03

Brand Name : XYLOCAINE DENTAL LID...

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : XYLOCAINE DENTAL LID...

U.S.A

2024 ACI Convention

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Regulatory Info : Ethical

Registration Country : Canada

EPINEPHRINE

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : XYLOCAINE DENTAL LIDOCAIN...

Dosage Strength : 0.01MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2331640

Regulatory Info : Ethical

Registration Country : Canada

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04

Brand Name : 4% CITANEST FORTE DE...

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : 4% CITANEST FORTE DE...

U.S.A

2024 ACI Convention

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Regulatory Info : Ethical

Registration Country : Canada

EPINEPHRINE

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : 4% CITANEST FORTE DENTAL ...

Dosage Strength : 0.005MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2347695

Regulatory Info : Ethical

Registration Country : Canada

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05

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

2024 ACI Convention

Not Confirmed

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Regulatory Info : Ethical

Registration Country : Canada

EPINEPHRINE (EPINEPHRINE BITARTRATE)

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : 4% ASTRACAINE DENTAL WITH...

Dosage Strength : 0.01MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2248488

Regulatory Info : Ethical

Registration Country : Canada

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06

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : 4% ASTRACAINE DENTAL...

U.S.A

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Ethical

Registration Country : Canada

EPINEPHRINE (EPINEPHRINE BITARTRATE)

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : 4% ASTRACAINE DENTAL WITH...

Dosage Strength : 0.005MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2248489

Regulatory Info : Ethical

Registration Country : Canada

Product
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07

Brand Name : XYLOCAINE DENTAL LID...

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : XYLOCAINE DENTAL LID...

U.S.A

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Ethical

Registration Country : Canada

EPINEPHRINE (EPINEPHRINE BITARTRATE)

DENTSPLY PHARM

Dosage Form : SOLUTION

Brand Name : XYLOCAINE DENTAL LIDOCAIN...

Dosage Strength : 0.02MG/ML

Packaging : 1.8ML

Approval Date :

Application Number : 2345072

Regulatory Info : Ethical

Registration Country : Canada

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08

Brand Name : DURANEST

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : DURANEST

U.S.A

2024 ACI Convention

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Digital Content

Regulatory Info : DISCN

Registration Country : USA

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE;INJECTION

Brand Name : DURANEST

Dosage Strength : 0.005MG/ML;1.5% **Fede...

Packaging :

Approval Date : 1982-01-01

Application Number : 21384

Regulatory Info : DISCN

Registration Country : USA

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09

Brand Name : CITANEST FORTE DENTA...

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : CITANEST FORTE DENTA...

U.S.A

2024 ACI Convention

Not Confirmed

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Regulatory Info : RX

Registration Country : USA

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE;INJECTION

Brand Name : CITANEST FORTE DENTAL

Dosage Strength : 0.005MG/ML;4%

Packaging :

Approval Date : 1982-01-01

Application Number : 21383

Regulatory Info : RX

Registration Country : USA

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10

Brand Name : XYLOCAINE DENTAL WIT...

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : XYLOCAINE DENTAL WIT...

U.S.A

2024 ACI Convention

Not Confirmed

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Regulatory Info : DISCN

Registration Country : USA

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE;INJECTION

Brand Name : XYLOCAINE DENTAL WITH EPI...

Dosage Strength : 0.02MG/ML;2% **Federal...

Packaging :

Approval Date : 1982-01-01

Application Number : 21381

Regulatory Info : DISCN

Registration Country : USA

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