Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078987
Company: GLENMARK PHARMS

Products on ANDA 078987

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LINEZOLID	LINEZOLID	600MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078987

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/21/2015	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/31/2018	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078987

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
LINEZOLID	LINEZOLID	600MG	TABLET;ORAL	Prescription	No	AB	205517	ALKEM LABS LTD
LINEZOLID	LINEZOLID	600MG	TABLET;ORAL	Prescription	No	AB	210702	CHARTWELL RX
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	078845	RISING
LINEZOLID	LINEZOLID	600MG	TABLET;ORAL	Prescription	No	AB	206097	ZYDUS PHARMS
ZYVOX	LINEZOLID	600MG	TABLET;ORAL	Prescription	Yes	AB	021130	PFIZER