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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200904
Company: SANDOZ

Products on ANDA 200904

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 200904

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2015	ORIG-2	Approval	Not Applicable			Label is not available on this site.
07/16/2015	ORIG-1	Approval	Not Applicable		Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200904Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200904Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/22/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/22/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
12/22/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/28/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/28/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200904

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	205154	MYLAN LABS LTD
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	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	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	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
ZYVOX	LINEZOLID	600MG/300ML (2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	021131	PFIZER

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