Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210702
Company: CELLTRION
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
04/25/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/19/2021 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

11/01/2019 SUPPL-1 Labeling-Container/Carton Labels

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 210702 CELLTRION
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 207526 NOVEL LABS INC
LINEZOLID LINEZOLID 600MG TABLET;ORAL Prescription No AB 206097 ZYDUS PHARMS
ZYVOX LINEZOLID 600MG TABLET;ORAL Prescription Yes AB 021130 PFIZER

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