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Approved Drug Products containing Citanest Octapressin listed in the FDA Orange Book. Original Data : FDA Website

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01 5ASTRAZENECA

02 2DENTSPLY PHARM

03 2SEPTODONT INC

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PharmaCompass

01

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

PRILOCAINE HYDROCHLORIDE

Brand Name : CITANEST

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 14763

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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02

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

PRILOCAINE HYDROCHLORIDE

Brand Name : CITANEST

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 14763

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

PRILOCAINE HYDROCHLORIDE

Brand Name : CITANEST

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 14763

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

PRILOCAINE HYDROCHLORIDE

Brand Name : CITANEST PLAIN

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 14763

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

Brand Name : CITANEST FORTE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.005MG/ML;4%

Approval Date : 1982-01-01

Application Number : 14763

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

PRILOCAINE HYDROCHLORIDE

Brand Name : CITANEST PLAIN DENTAL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4%

Approval Date : 1982-01-01

Application Number : 21382

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

Brand Name : CITANEST FORTE DENTAL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.005MG/ML;4%

Approval Date : 1982-01-01

Application Number : 21383

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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08

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

Brand Name : PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 0.005MG/ML;4%

Approval Date : 2011-08-30

Application Number : 78959

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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09

FNCE 2024
Not Confirmed
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FNCE 2024
Not Confirmed

PRILOCAINE HYDROCHLORIDE

Brand Name : PRILOCAINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 4%

Approval Date : 2010-09-29

Application Number : 79235

RX/OTC/DISCN : RX

RLD : No

TE Code :

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