Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078061
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription AB 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
05/18/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078061Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

10/28/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LINEZOLID

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 205233 ALEMBIC PHARMS LTD
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 205517 ALKEM LABS LTD
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 204536 AMNEAL PHARMS
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 091210 GATE PHARMS
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 078987 GLENMARK PHARMS
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 204239 HETERO LABS LTD V
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 078845 MYLAN PHARMS INC
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 207526 NOVEL LABS INC
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 078061 TEVA PHARMS USA
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 206097 ZYDUS PHARMS USA INC
ZYVOX LINEZOLID 600MG TABLET;ORAL Prescription Yes AB 021130 PHARMACIA AND UPJOHN

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