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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 eight 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 NDA: 020971

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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