Details for New Drug Application (NDA): 208475

NDA 208475 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 208475

Tradename:	LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
Applicant:	B Braun Medical Inc
Ingredient:	epinephrine; lidocaine hydrochloride
Patents:	0

Pharmacology for NDA: 208475

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

Suppliers and Packaging for NDA: 208475

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	208475	ANDA	B. Braun Medical Inc.	0264-9378	0264-9378-05	5 AMPULE in 1 CARTON (0264-9378-05) / 5 mL in 1 AMPULE (0264-9378-88)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.005MG/ML;1.5%
Approval Date:	Sep 8, 2021	TE:	AP	RLD:	No

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