Details for New Drug Application (NDA): 089645

NDA 089645 describes LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, which is a drug marketed by B Braun Medical Inc, Belmora Llc, Eastman Kodak, Hospira, West-ward Pharms Int, and Empi, and is included in fourteen NDAs. It is available from five suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for 089645

Tradename:	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
Applicant:	Hospira
Ingredient:	epinephrine; lidocaine hydrochloride
Patents:	0

Pharmacology for NDA: 089645

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

Suppliers and Packaging for NDA: 089645

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	089645	ANDA	Hospira, Inc.	0409-3181	0409-3181-01	5 VIAL, SINGLE-DOSE in 1 CARTON (0409-3181-01) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-3181-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.005MG/ML;1.5%
Approval Date:	Jun 21, 1988	TE:	AP	RLD:	No

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