Details for New Drug Application (NDA): 020971

NDA 020971 describes SEPTOCAINE, which is a drug marketed by Deproco and is included in one NDA. It is available from seven suppliers. Additional details are available on the SEPTOCAINE profile page.

The generic ingredient in SEPTOCAINE is articaine hydrochloride; epinephrine bitartrate. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the articaine hydrochloride; epinephrine bitartrate profile page.

Summary for 020971

Tradename:	SEPTOCAINE
Applicant:	Deproco
Ingredient:	articaine hydrochloride; epinephrine bitartrate
Patents:	0

Pharmacology for NDA: 020971

Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 020971

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEPTOCAINE	articaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	020971	NDA AUTHORIZED GENERIC	Septodont, Inc.	0362-0830	0362-0830-05	50 CARTRIDGE in 1 CARTON (0362-0830-05) / 1.7 mL in 1 CARTRIDGE
SEPTOCAINE	articaine hydrochloride; epinephrine bitartrate	INJECTABLE;INJECTION	020971	NDA	Septodont Inc.	0362-9048	0362-9048-02	50 CARTRIDGE in 1 CARTON (0362-9048-02) / 1.7 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)
Approval Date:	Apr 3, 2000	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)
Approval Date:	Mar 30, 2006	TE:		RLD:	Yes

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