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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 009435

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NESACAINE (CHLOROPROCAINE HYDROCHLORIDE)
1%
Marketing Status: Prescription
Active Ingredient: CHLOROPROCAINE HYDROCHLORIDE
Proprietary Name: NESACAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N009435
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NESACAINE (CHLOROPROCAINE HYDROCHLORIDE)
2%
Marketing Status: Prescription
Active Ingredient: CHLOROPROCAINE HYDROCHLORIDE
Proprietary Name: NESACAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2%
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N009435
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NESACAINE-MPF (CHLOROPROCAINE HYDROCHLORIDE)
2%
Marketing Status: Prescription
Active Ingredient: CHLOROPROCAINE HYDROCHLORIDE
Proprietary Name: NESACAINE-MPF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N009435
Product Number: 006
Approval Date: May 2, 1996
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NESACAINE-MPF (CHLOROPROCAINE HYDROCHLORIDE)
3%
Marketing Status: Prescription
Active Ingredient: CHLOROPROCAINE HYDROCHLORIDE
Proprietary Name: NESACAINE-MPF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N009435
Product Number: 007
Approval Date: May 2, 1996
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NESACAINE-MPF (CHLOROPROCAINE HYDROCHLORIDE)
2%
Marketing Status: Discontinued
Active Ingredient: CHLOROPROCAINE HYDROCHLORIDE
Proprietary Name: NESACAINE-MPF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N009435
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
NESACAINE-MPF (CHLOROPROCAINE HYDROCHLORIDE)
3%
Marketing Status: Discontinued
Active Ingredient: CHLOROPROCAINE HYDROCHLORIDE
Proprietary Name: NESACAINE-MPF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N009435
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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