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Generated: November 17, 2018

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Details for New Drug Application (NDA): 018304

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NDA 018304 describes SENSORCAINE, which is a drug marketed by Fresenius Kabi Usa and is included in eight NDAs. It is available from three suppliers. Additional details are available on the SENSORCAINE profile page.

The generic ingredient in SENSORCAINE is bupivacaine hydrochloride. There are eleven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
Summary for 018304
Tradename:SENSORCAINE
Applicant:Fresenius Kabi Usa
Ingredient:bupivacaine hydrochloride; epinephrine bitartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018304
Suppliers and Packaging for NDA: 018304
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SENSORCAINE bupivacaine hydrochloride INJECTABLE;INJECTION 018304 ANDA General Injectables & Vaccines, Inc 52584-465 52584-465-57 1 VIAL in 1 BAG (52584-465-57) > 50 mL in 1 VIAL
SENSORCAINE bupivacaine hydrochloride INJECTABLE;INJECTION 018304 ANDA General Injectables & Vaccines, Inc 52584-467 52584-467-57 1 VIAL in 1 BAG (52584-467-57) > 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.75%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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