Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200904
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LINEZOLID LINEZOLID 200MG/100ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription AP No No
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;IV (INFUSION) 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

LINEZOLID

SOLUTION;IV (INFUSION); 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;IV (INFUSION) Prescription No AP 207001 HQ SPCLT PHARMA
LINEZOLID LINEZOLID 200MG/100ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 205154 MYLAN LABS LTD
LINEZOLID LINEZOLID 200MG/100ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 207354 NANG KUANG PHARM CO
LINEZOLID LINEZOLID 200MG/100ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 204696 SAGENT PHARMS
LINEZOLID LINEZOLID 200MG/100ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 200904 SANDOZ INC
ZYVOX LINEZOLID 200MG/100ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription Yes AP 021131 PHARMACIA AND UPJOHN

SOLUTION;IV (INFUSION); 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;IV (INFUSION) Prescription No AP 206917 AUROBINDO PHARMA LTD
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 204764 FRESENIUS KABI USA
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 205442 HOSPIRA INC
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 207001 HQ SPCLT PHARMA
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 205154 MYLAN LABS LTD
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 207354 NANG KUANG PHARM CO
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 204696 SAGENT PHARMS
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 200904 SANDOZ INC
LINEZOLID LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 200222 TEVA PHARMS
ZYVOX LINEZOLID 600MG/300ML (2MG/ML) SOLUTION;IV (INFUSION) Prescription Yes AP 021131 PHARMACIA AND UPJOHN

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English