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Drugs@FDA: FDA-Approved Drugs

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

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

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
07/03/2025 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
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.

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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