Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200222
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/27/2012 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200222s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/05/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

01/05/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LINEZOLID

SOLUTION;INTRAVENOUS; 600MG/300ML (2MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 206917 AUROBINDO PHARMA LTD
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 204764 FRESENIUS KABI USA
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205442 HOSPIRA INC
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 207001 HQ SPCLT PHARMA
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205154 MYLAN LABS LTD
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 207354 NANG KUANG PHARM CO
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 204696 SAGENT PHARMS INC
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 200904 SANDOZ INC
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 200222 TEVA PHARMS
ZYVOX LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 021131 PHARMACIA AND UPJOHN

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