Product Details for NDA 020997
CHIROCAINE (LEVOBUPIVACAINE HYDROCHLORIDE)
EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 7.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LEVOBUPIVACAINE HYDROCHLORIDE
Proprietary Name: CHIROCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020997
Product Number: 001
Approval Date: Aug 5, 1999
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status: Discontinued
Patent and Exclusivity Information
CHIROCAINE (LEVOBUPIVACAINE HYDROCHLORIDE)
Proprietary Name: CHIROCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020997
Product Number: 001
Approval Date: Aug 5, 1999
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LEVOBUPIVACAINE HYDROCHLORIDE
Proprietary Name: CHIROCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020997
Product Number: 002
Approval Date: Aug 5, 1999
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status: Discontinued
Patent and Exclusivity Information
CHIROCAINE (LEVOBUPIVACAINE HYDROCHLORIDE)
Proprietary Name: CHIROCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020997
Product Number: 002
Approval Date: Aug 5, 1999
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 7.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LEVOBUPIVACAINE HYDROCHLORIDE
Proprietary Name: CHIROCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 7.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020997
Product Number: 003
Approval Date: Aug 5, 1999
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CHIROCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 7.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020997
Product Number: 003
Approval Date: Aug 5, 1999
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status: Discontinued
Patent and Exclusivity Information