Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020971

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SEPTOCAINE (ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE)
4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Proprietary Name: SEPTOCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020971
Product Number: 002
Approval Date: Mar 30, 2006
Applicant Holder Full Name: DEPROCO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

SEPTOCAINE (ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE)
4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Proprietary Name: SEPTOCAINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020971
Product Number: 001
Approval Date: Apr 3, 2000
Applicant Holder Full Name: DEPROCO INC
Marketing Status:  Prescription
Patent and Exclusivity Information