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DENTSPLY PHARM
FDA Orange Book

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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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

Contact Details

CONTACT DETAILS
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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

9 All

01 1EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

02 1EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

03 2EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

04 1LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

05 1LIDOCAINE HYDROCHLORIDE

06 1LIDOCAINE; PRILOCAINE

07 1MEPIVACAINE HYDROCHLORIDE

08 1PRILOCAINE HYDROCHLORIDE

filter Dosage Reset all filters

9 All

01 1GEL;PERIODONTAL

02 8INJECTABLE;INJECTION

filter Dosage Strength Reset all filters

9 All

01 10.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

02 10.005MG/ML;4%

03 10.01MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

04 10.02MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

05 10.05MG/ML;2%

06 12%

07 12.5%;2.5%

08 13%

09 14%

filter Regulatory Info Reset all filters

9 All

01 7DISCN

02 2RX

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01

Brand Name : DURANEST

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : DURANEST

U.S.A

2024 ACI Convention

Not Confirmed

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RLD : Yes

TE Code :

EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : DURANEST

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

Approval Date : 1982-01-01

Application Number : 21384

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Product
Web Link

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#PipelineProspector

02

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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RLD : Yes

TE Code : AP

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : CITANEST FORTE DENTAL

Dosage Strength : 0.005MG/ML;4%

Approval Date : 1982-01-01

Application Number : 21383

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Product
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03

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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Digital Content

RLD : No

TE Code :

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : XYLOCAINE DENTAL WITH EP...

Dosage Strength : 0.01MG/ML;2% **Federal R...

Approval Date : 1982-01-01

Application Number : 21381

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

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04

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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RLD : No

TE Code :

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : XYLOCAINE DENTAL WITH EP...

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

Approval Date : 1982-01-01

Application Number : 21381

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
#PipelineProspector

05

Brand Name : POLOCAINE W/ LEVONOR...

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : POLOCAINE W/ LEVONOR...

U.S.A

2024 ACI Convention

Not Confirmed

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Digital Content

RLD : No

TE Code :

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : POLOCAINE W/ LEVONORDEFR...

Dosage Strength : 0.05MG/ML;2%

Approval Date : 1988-04-14

Application Number : 89517

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

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06

Brand Name : XYLOCAINE DENTAL

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : XYLOCAINE DENTAL

U.S.A

2024 ACI Convention

Not Confirmed

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RLD : No

TE Code :

LIDOCAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : XYLOCAINE DENTAL

Dosage Strength : 2%

Approval Date : 1982-01-01

Application Number : 21380

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
Web Link

Stock Recap
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07

Brand Name : ORAQIX

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : ORAQIX

U.S.A

2024 ACI Convention

Not Confirmed

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RLD : Yes

TE Code :

LIDOCAINE; PRILOCAINE

DENTSPLY PHARM

Dosage Form : GEL; PERIODONTAL

Proprietary Name : ORAQIX

Dosage Strength : 2.5%;2.5%

Approval Date : 2003-12-19

Application Number : 21451

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product
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08

Brand Name : POLOCAINE

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : POLOCAINE

U.S.A

2024 ACI Convention

Not Confirmed

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RLD : No

TE Code :

MEPIVACAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : POLOCAINE

Dosage Strength : 3%

Approval Date : 1984-08-21

Application Number : 88653

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product
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09

Brand Name : CITANEST PLAIN DENTA...

U.S.A

2024 ACI Convention

Not Confirmed

Brand Name : CITANEST PLAIN DENTA...

U.S.A

2024 ACI Convention

Not Confirmed

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RLD : Yes

TE Code :

PRILOCAINE HYDROCHLORIDE

DENTSPLY PHARM

Dosage Form : INJECTABLE; INJECTION

Proprietary Name : CITANEST PLAIN DENTAL

Dosage Strength : 4%

Approval Date : 1982-01-01

Application Number : 21382

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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