FDA.reportPublic FDA data

Application 207001

Type
ANDA
Sponsor
HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LINEZOLIDLINEZOLIDSOLUTION;INTRAVENOUS200MG/100ML (2MG/ML)NoNo
002LINEZOLIDLINEZOLIDSOLUTION;INTRAVENOUS600MG/300ML (2MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66794-219LinezolidLinezolidPiramal Critical Care IncANDACurrent
66794-219LinezolidLinezolidPiramal Critical Care IncANDACurrent
66794-219LinezolidLinezolidPiramal Critical Care IncANDACurrent
66794-219LinezolidLinezolidPiramal Critical Care IncANDACurrent
66794-219LinezolidLinezolidPiramal Critical Care IncANDACurrent
66794-219LinezolidLinezolidPiramal Critical Care IncANDACurrent
66794-236LinezolidLinezolidPiramal Critical Care Inc.ANDACurrent
66794-236LinezolidLinezolidPiramal Critical Care Inc.ANDACurrent
66794-236LinezolidLinezolidPiramal Critical Care Inc.ANDACurrent
66794-236LinezolidLinezolidPiramal Critical Care Inc.ANDACurrent