POSIMIR- bupivacaine injection

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

BUPIVACAINE (UNII: Y8335394RO) (BUPIVACAINE - UNII:Y8335394RO)

Dostupné s:

Renaissance Lakewood, LLC

Podání:

INFILTRATION

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

New Drug Application

Charakteristika produktu

POSIMIR- BUPIVACAINE INJECTION
RENAISSANCE LAKEWOOD, LLC
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POSIMIR (BUPIVACAINE SOLUTION) 660 MG/5ML (132 MG/ML)
Product Label
Product Vial
Product Carton
POSIMIR
bupivacaine injection
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:49396-6601
ROUTE OF ADMINISTRATION
INFILTRATION
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BUPIVACAINE (UNII: Y8335394RO) (BUPIVACAINE - UNII:Y8335394RO)
BUPIVACAINE
660 mg in 5 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
BENZYL ALCOHOL (UNII: LKG8494WBH)
SUCROSE ACETATE ISOBUTYRATE (UNII: H5KI1C3YTV)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:49396-
6601-0
10 in 1 CARTON
05/31/2022
1
5 mL in 1 BOTTLE; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
NDA
NDA204803
05/31/2022
Renaissance Lakewood, LLC
LABELER -
Renaissance Lakewood, LLC (077744035)
REGISTRANT -
Renaissance Lakewood, LLC (077744035)
Revised: 12/2022