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Generated: May 25, 2019

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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 twelve 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 070553
Applicant:Fresenius Kabi Usa
Ingredient:bupivacaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 070553
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

Profile for product number 001

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

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