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Details for New Drug Application (NDA): 070966

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NDA 070966 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; epinephrine bitartrate. There are ten drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.

Summary for NDA: 070966

Tradename:
SENSORCAINE
Applicant:
Fresenius Kabi Usa
Ingredient:
bupivacaine hydrochloride; epinephrine bitartrate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 070966

Suppliers and Packaging for NDA: 070966

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SENSORCAINE
bupivacaine hydrochloride; epinephrine bitartrate
INJECTABLE;INJECTION 070966 ANDA Fresenius Kabi USA, LLC 63323-468 63323-468-17 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-468-17) > 10 mL in 1 VIAL, SINGLE-DOSE
SENSORCAINE
bupivacaine hydrochloride; epinephrine bitartrate
INJECTABLE;INJECTION 070966 ANDA Fresenius Kabi USA, LLC 63323-468 63323-468-37 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-468-37) > 30 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.25%;0.0091MG/ML
Approval Date:Oct 13, 1987TE:APRLD:No


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