Orabloc - 45146-110-01 - (articaine hydrochloride and epinephrine bitartrate)

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Drug Information of Orabloc

Product NDC: 45146-110
Proprietary Name: Orabloc
Non Proprietary Name: articaine hydrochloride and epinephrine bitartrate
Active Ingredient(s): 40; 10    mg/mL; ug/mL & nbsp;   articaine hydrochloride and epinephrine bitartrate
Administration Route(s): SUBMUCOSAL
Dosage Form(s): INJECTION
Coding System: National Drug Codes(NDC)

Labeler Information of Orabloc

Product NDC: 45146-110
Labeler Name: Pierrel S.p.A.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022466
Marketing Category: NDA
Start Marketing Date: 20110215

Package Information of Orabloc

Package NDC: 45146-110-01
Package Description: 100 CARTRIDGE in 1 BOX (45146-110-01) > 1.8 mL in 1 CARTRIDGE

NDC Information of Orabloc

NDC Code 45146-110-01
Proprietary Name Orabloc
Package Description 100 CARTRIDGE in 1 BOX (45146-110-01) > 1.8 mL in 1 CARTRIDGE
Product NDC 45146-110
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name articaine hydrochloride and epinephrine bitartrate
Dosage Form Name INJECTION
Route Name SUBMUCOSAL
Start Marketing Date 20110215
Marketing Category Name NDA
Labeler Name Pierrel S.p.A.
Substance Name ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Strength Number 40; 10
Strength Unit mg/mL; ug/mL
Pharmaceutical Classes Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]

Complete Information of Orabloc


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