Details for New Drug Application (NDA): 070966

NDA 070966 describes SENSORCAINE, which is a drug marketed by Fresenius Kabi Usa and is included in eight NDAs. It is available from four 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. Twenty-one suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.

Summary for 070966

Tradename:	SENSORCAINE
Applicant:	Fresenius Kabi Usa
Ingredient:	bupivacaine hydrochloride; epinephrine bitartrate
Patents:	0

Pharmacology for NDA: 070966

Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Local Anesthesia

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 (63323-468-01)
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 (63323-468-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.25%;0.0091MG/ML
Approval Date:	Oct 13, 1987	TE:	AP	RLD:	No

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