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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018304

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SENSORCAINE (BUPIVACAINE HYDROCHLORIDE)
0.25%
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE
Proprietary Name: SENSORCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.25%
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N018304
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
SENSORCAINE (BUPIVACAINE HYDROCHLORIDE)
0.5%
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE
Proprietary Name: SENSORCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5%
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N018304
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
SENSORCAINE (BUPIVACAINE HYDROCHLORIDE)
0.75%
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE
Proprietary Name: SENSORCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.75%
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N018304
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
SENSORCAINE (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE)
0.5%;0.0091MG/ML
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Proprietary Name: SENSORCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5%;0.0091MG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N018304
Product Number: 004
Approval Date: Sep 2, 1983
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
SENSORCAINE (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE)
0.75%;0.0091MG/ML
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Proprietary Name: SENSORCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.75%;0.0091MG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N018304
Product Number: 005
Approval Date: Sep 2, 1983
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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