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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070553

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NDA 070553 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 ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.

Summary for 070553

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 070553

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 070553

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SENSORCAINE bupivacaine hydrochloride INJECTABLE;INJECTION 070553 ANDA General Injectables & Vaccines, Inc 52584-466 52584-466-17 1 VIAL in 1 BAG (52584-466-17) > 10 mL in 1 VIAL
SENSORCAINE bupivacaine hydrochloride INJECTABLE;INJECTION 070553 ANDA Fresenius Kabi USA, LLC 63323-466 63323-466-31 5 BLISTER PACK in 1 BOX (63323-466-31) > 1 VIAL in 1 BLISTER PACK > 30 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%
Approval Date:May 21, 1986TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Medtronic
Chubb
Novartis
Colorcon
Cipla
McKesson
Accenture
Moodys
Cantor Fitzgerald

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