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Product Details for NDA 016964

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MARCAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
0.25%
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE
Proprietary Name: MARCAINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.25%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016964
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MARCAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
0.5%
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE
Proprietary Name: MARCAINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016964
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE (BUPIVACAINE HYDROCHLORIDE)
0.25%
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE
Proprietary Name: MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.25%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016964
Product Number: 012
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE (BUPIVACAINE HYDROCHLORIDE)
0.5%
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE
Proprietary Name: MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016964
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE (BUPIVACAINE HYDROCHLORIDE)
0.75%
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE
Proprietary Name: MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.75%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016964
Product Number: 009
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE)
0.25%;0.0091MG/ML
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Proprietary Name: MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.25%;0.0091MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016964
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE)
0.5%;0.0091MG/ML
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Proprietary Name: MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5%;0.0091MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016964
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE)
0.25%;0.0091MG/ML
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Proprietary Name: MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.25%;0.0091MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016964
Product Number: 013
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE)
0.5%;0.0091MG/ML
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Proprietary Name: MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5%;0.0091MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016964
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE (BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE)
0.75%;0.0091MG/ML
Marketing Status: Prescription
Active Ingredient: BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Proprietary Name: MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.75%;0.0091MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N016964
Product Number: 010
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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