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Details for New Drug Application (NDA): 020971

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NDA 020971 describes SEPTOCAINE, which is a drug marketed by Deproco and is included in two NDAs. 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. Ten suppliers are listed for this compound. Additional details are available on the articaine hydrochloride; epinephrine bitartrate profile page.

Summary for NDA: 020971

Tradename:
SEPTOCAINE
Applicant:
Deproco
Ingredient:
articaine hydrochloride; epinephrine bitartrate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020971

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 Septodont Inc. 0362-9048 0362-9048-02 50 CARTRIDGE in 1 CARTON (0362-9048-02) > 1.7 mL in 1 CARTRIDGE
SEPTOCAINE
articaine hydrochloride; epinephrine bitartrate
INJECTABLE;INJECTION 020971 NDA Septodont Inc. 0362-9049 0362-9049-02 50 CARTRIDGE in 1 CARTON (0362-9049-02) > 1.7 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)
Approval Date:Apr 3, 2000TE:APRLD:Yes


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