LINEZOLID tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

LINEZOLID (UNII: ISQ9I6J12J) (LINEZOLID - UNII:ISQ9I6J12J)

Saatavilla:

Zydus Lifesciences Limited

INN (Kansainvälinen yleisnimi):

LINEZOLID

Koostumus:

LINEZOLID 600 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Linezolid tablet is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid tablet is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [see Warnings and Precautions (5.4) ]. Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14) ]. Community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14) ]. Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis , caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogen

Tuoteyhteenveto:

Linezolid Tablets, 600 mg are white to off-white, oval-shape, biconvex, film-coated tablets debossed with '413' on one side and plain on other side and are supplied as follows: NDC 70771-1111-2 in bottle of 20 tablets NDC 70771-1111-3 in bottle of 30 tablets NDC 70771-1111-9 in bottle of 90 tablets NDC 70771-1111-1 in bottle of 100 tablets NDC 70771-1111-5 in bottle of 500 tablets NDC 70771-1111-0 in bottle of 1000 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Keep bottles tightly closed to protect from moisture.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

LINEZOLID - LINEZOLID TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
LINEZOLID TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1111-1
Linezolid Tablets, 600 mg
Rx only
100 tablets
LINEZOLID
linezolid tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1111
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LINEZOLID (UNII: ISQ9I6J12J) (LINEZOLID - UNII:ISQ9I6J12J)
LINEZ OLID
600 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
OVAL (OVAL)
SIZE
19mm
FLAVOR
IMPRINT CODE
413
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1111-2
20 in 1 BOTTLE; Type 0: Not a Combination
Product
08/09/2017
2
NDC:70771-
1111-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
08/09/2017
3
NDC:70771-
1111-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
08/09/2017
4
NDC:70771-
1111-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
08/09/2017
5
NDC:70771-
1111-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
08/09/2017
6
NDC:70771-
1111-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
08/09/2017
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA206097
08/09/2017
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
Zydus Lifesciences Limited
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
863362789
ANALYSIS(70771-1111) , MANUFACTURE(70771-1111)
Revised: 10/2022