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Serving leading biopharmaceutical companies globally:

Deloitte
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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070552

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NDA 070552 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. Twelve suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
Summary for 070552
Tradename:SENSORCAINE
Applicant:Fresenius Kabi Usa
Ingredient:bupivacaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 070552
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 070552
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SENSORCAINE bupivacaine hydrochloride INJECTABLE;INJECTION 070552 ANDA Fresenius Kabi USA, LLC 63323-464 63323-464-37 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-464-37) > 30 mL in 1 VIAL, SINGLE-DOSE
SENSORCAINE bupivacaine hydrochloride INJECTABLE;INJECTION 070552 ANDA Fresenius Kabi USA, LLC 63323-464 63323-464-31 5 BLISTER PACK in 1 BOX (63323-464-31) > 1 VIAL in 1 BLISTER PACK > 30 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%
Approval Date:May 21, 1986TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Cipla
Harvard Business School
Covington
Citi
Chubb
Express Scripts
Queensland Health
US Army
Farmers Insurance

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