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Approved Drug Products containing Ropivacaine HCl listed in the FDA Orange Book. Original Data : FDA Website

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01 4AMNEAL

02 6CAPLIN

03 7EUGIA PHARMA

04 13FRESENIUS KABI USA

05 2GLAND PHARMA LTD

06 7HIKMA

07 6HOSPIRA

08 4INFORLIFE

09 7KINDOS

10 2MYLAN LABS LTD

11 3NAVINTA LLC

12 4RISING

13 3RISING PHARMA

14 7SOMERSET THERAPS LLC

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PharmaCompass

01

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Not Confirmed
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ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION;INJECTION

Dosage Strength : 20MG/10ML (2MG/ML)

Approval Date : 1998-05-01

Application Number : 20533

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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02

Luxepack
Not Confirmed
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ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION;INJECTION

Dosage Strength : 40MG/20ML (2MG/ML)

Approval Date : 1996-09-24

Application Number : 20533

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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03

Luxepack
Not Confirmed
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Luxepack
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ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION;INJECTION

Dosage Strength : 100MG/20ML (5MG/ML)

Approval Date : 1998-05-01

Application Number : 20533

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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04

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION;INJECTION

Dosage Strength : 150MG/20ML (7.5MG/ML)

Approval Date : 1996-09-24

Application Number : 20533

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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05

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION;INJECTION

Dosage Strength : 100MG/10ML (10MG/ML)

Approval Date : 1996-09-24

Application Number : 20533

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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06

Luxepack
Not Confirmed
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Luxepack
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ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION;INJECTION

Dosage Strength : 200MG/100ML (2MG/ML)

Approval Date : 1996-09-24

Application Number : 20533

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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07

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION;INJECTION

Dosage Strength : 400MG/200ML (2MG/ML)

Approval Date : 1996-09-24

Application Number : 20533

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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08

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Not Confirmed
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ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION;INJECTION

Dosage Strength : 150MG/30ML (5MG/ML)

Approval Date : 1996-09-24

Application Number : 20533

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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09

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ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION;INJECTION

Dosage Strength : 500MG/100ML (5MG/ML)

Approval Date : 2011-01-04

Application Number : 20533

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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10

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ROPIVACAINE HYDROCHLORIDE

Brand Name : NAROPIN

Dosage Form : SOLUTION;INJECTION

Dosage Strength : 1GM/200ML (5MG/ML)

Approval Date : 2011-01-04

Application Number : 20533

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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