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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204696
Company: SAGENT PHARMS INC

Products on ANDA 204696

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LINEZOLID	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
LINEZOLID	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204696

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/02/2017	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
02/28/2024	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/28/2024	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/28/2024	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
06/28/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204696

LINEZOLID

SOLUTION;INTRAVENOUS; 200MG/100ML (2MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LINEZOLID	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207001	HQ SPCLT PHARMA
LINEZOLID	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207354	NANG KUANG PHARM CO
LINEZOLID	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	205154	PHARMOBEDIENT
LINEZOLID	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	204696	SAGENT PHARMS INC
LINEZOLID	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	200904	SANDOZ
ZYVOX	LINEZOLID	200MG/100ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	021131	PFIZER

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	219558	CAPLIN
LINEZOLID	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	206917	EUGIA PHARMA
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	206454	HIKMA
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	207354	NANG KUANG PHARM CO
LINEZOLID	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	205154	PHARMOBEDIENT
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
ZYVOX	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	021131	PFIZER

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