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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090194

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ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
20MG/10ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: ROPIVACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 20MG/10ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A090194
Product Number: 001
Approval Date: Sep 23, 2014
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
40MG/20ML (2MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: ROPIVACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 40MG/20ML (2MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A090194
Product Number: 005
Approval Date: Sep 23, 2014
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
100MG/10ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: ROPIVACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 100MG/10ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A090194
Product Number: 004
Approval Date: Sep 23, 2014
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
150MG/20ML (7.5MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: ROPIVACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 150MG/20ML (7.5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A090194
Product Number: 003
Approval Date: Sep 23, 2014
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
150MG/30ML (5MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: ROPIVACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 150MG/30ML (5MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A090194
Product Number: 002
Approval Date: Sep 23, 2014
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE HYDROCHLORIDE)
200MG/20ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: ROPIVACAINE HYDROCHLORIDE
Proprietary Name: ROPIVACAINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INJECTION
Strength: 200MG/20ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A090194
Product Number: 006
Approval Date: Sep 23, 2014
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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