Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 014763

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CITANEST FORTE (EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE)
0.005MG/ML;4%
Marketing Status: Discontinued

Active Ingredient: EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE
Proprietary Name: CITANEST FORTE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.005MG/ML;4%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N014763
Product Number: 008
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

CITANEST (PRILOCAINE HYDROCHLORIDE)
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: PRILOCAINE HYDROCHLORIDE
Proprietary Name: CITANEST
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N014763
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

CITANEST (PRILOCAINE HYDROCHLORIDE)
2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: PRILOCAINE HYDROCHLORIDE
Proprietary Name: CITANEST
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N014763
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

CITANEST (PRILOCAINE HYDROCHLORIDE)
3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: PRILOCAINE HYDROCHLORIDE
Proprietary Name: CITANEST
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3% **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: N014763
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

CITANEST PLAIN (PRILOCAINE HYDROCHLORIDE)
4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: PRILOCAINE HYDROCHLORIDE
Proprietary Name: CITANEST PLAIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 4% **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: N014763
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information