Product Details for NDA 021381
XYLOCAINE DENTAL WITH EPINEPHRINE (EPINEPHRINE; LIDOCAINE HYDROCHLORIDE)
0.01MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.02MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
0.01MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Proprietary Name: XYLOCAINE DENTAL WITH EPINEPHRINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.01MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021381
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: DENTSPLY PHARMACEUTICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
XYLOCAINE DENTAL WITH EPINEPHRINE (EPINEPHRINE; LIDOCAINE HYDROCHLORIDE)
Proprietary Name: XYLOCAINE DENTAL WITH EPINEPHRINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.01MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021381
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: DENTSPLY PHARMACEUTICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
0.02MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Proprietary Name: XYLOCAINE DENTAL WITH EPINEPHRINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.02MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021381
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: DENTSPLY PHARMACEUTICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: XYLOCAINE DENTAL WITH EPINEPHRINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 0.02MG/ML;2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N021381
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: DENTSPLY PHARMACEUTICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information