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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207001
Company: HQ SPCLT PHARMA

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
07/07/2017 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
01/10/2024 SUPPL-8 Labeling-Package Insert

Label is not available on this site.
01/10/2024 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
01/10/2024 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
01/10/2024 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
01/10/2024 SUPPL-2 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 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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