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Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070968

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NDA 070968 describes SENSORCAINE, which is a drug marketed by Fresenius Kabi Usa and is included in eight NDAs. It is available from two 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. Eleven suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
Summary for 070968
Applicant:Fresenius Kabi Usa
Ingredient:bupivacaine hydrochloride; epinephrine bitartrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 070968
Suppliers and Packaging for NDA: 070968
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SENSORCAINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 070968 ANDA Fresenius Kabi USA, LLC 63323-463 N 63323-463-57

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%;0.0091MG/ML
Approval Date:Oct 13, 1987TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
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