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Details for New Drug Application (NDA): 020997

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NDA 020997 describes CHIROCAINE, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. Additional details are available on the CHIROCAINE profile page.

The generic ingredient in CHIROCAINE is levobupivacaine hydrochloride. Additional details are available on the levobupivacaine hydrochloride profile page.

Summary for NDA: 020997

Tradename:
CHIROCAINE
Applicant:
Purdue Pharma Lp
Ingredient:
levobupivacaine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 2.5MG BASE/ML
Approval Date:Aug 5, 1999TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Aug 5, 1999TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 7.5MG BASE/ML
Approval Date:Aug 5, 1999TE:RLD:No

Expired Orange Book Patents for NDA: 020997

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp
CHIROCAINE
levobupivacaine hydrochloride
INJECTABLE;INJECTION020997-001Aug 5, 19995,708,011► subscribe
Purdue Pharma Lp
CHIROCAINE
levobupivacaine hydrochloride
INJECTABLE;INJECTION020997-003Aug 5, 19995,708,011► subscribe
Purdue Pharma Lp
CHIROCAINE
levobupivacaine hydrochloride
INJECTABLE;INJECTION020997-002Aug 5, 19995,708,011► subscribe
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