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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020533

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NAROPIN (ROPIVACAINE HYDROCHLORIDE)
20MG/10ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 20MG/10ML (2MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020533
Product Number: 001
Approval Date: May 1, 1998
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
40MG/20ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 40MG/20ML (2MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020533
Product Number: 002
Approval Date: Sep 24, 1996
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
100MG/20ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 100MG/20ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020533
Product Number: 003
Approval Date: May 1, 1998
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
100MG/10ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 100MG/10ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020533
Product Number: 005
Approval Date: Sep 24, 1996
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
150MG/20ML (7.5MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 150MG/20ML (7.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020533
Product Number: 004
Approval Date: Sep 24, 1996
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
150MG/30ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 150MG/30ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020533
Product Number: 008
Approval Date: Sep 24, 1996
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
200MG/100ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 200MG/100ML (2MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020533
Product Number: 006
Approval Date: Sep 24, 1996
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
200MG/20ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 200MG/20ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020533
Product Number: 011
Approval Date: Sep 24, 1996
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
400MG/200ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 400MG/200ML (2MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020533
Product Number: 007
Approval Date: Sep 24, 1996
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
500MG/100ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 500MG/100ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020533
Product Number: 009
Approval Date: Jan 4, 2011
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
1GM/200ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 1GM/200ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020533
Product Number: 010
Approval Date: Jan 4, 2011
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020533
Product Number: 013
Approval Date: May 1, 1998
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
NAROPIN (ROPIVACAINE HYDROCHLORIDE)
75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: NAROPIN
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020533
Product Number: 012
Approval Date: Sep 24, 1996
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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