Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
LINEZOLID (UNII: ISQ9I6J12J) (LINEZOLID - UNII:ISQ9I6J12J)
Zydus Lifesciences Limited
LINEZOLID
LINEZOLID 600 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Preberite celoten dokument