Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017751

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DURANEST (EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE)
0.005MG/ML;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE
Proprietary Name: DURANEST
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.005MG/ML;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017751
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

DURANEST (EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE)
0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE
Proprietary Name: DURANEST
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017751
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

DURANEST (EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE)
0.005MG/ML;0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE
Proprietary Name: DURANEST
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.005MG/ML;0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017751
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

DURANEST (ETIDOCAINE HYDROCHLORIDE)
0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: ETIDOCAINE HYDROCHLORIDE
Proprietary Name: DURANEST
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.5% **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: N017751
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

Active Ingredient: ETIDOCAINE HYDROCHLORIDE
Proprietary Name: DURANEST
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: N017751
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASTRAZENECA LP
Marketing Status:  Discontinued
Patent and Exclusivity Information