Application 050108

Type
NDA
Sponsor
PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002COLY-MYCIN MCOLISTIMETHATE SODIUMINJECTABLE;INJECTIONEQ 150MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42023-107Coly-MycincolistimethatePar Pharmaceutical, Inc.NDACurrent
42023-107Coly-MycincolistimethatePar Pharmaceutical, Inc.NDACurrent
42023-131Colistimethatecolistimethate sodiumPar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82753SUPPL 2025-07-08
82742SUPPL 2025-07-08
48057SUPPL2017-04-18
48051SUPPL2017-04-18
29980SUPPL2013-03-08
17800SUPPL2013-03-08
17799SUPPL2009-06-07
7693SUPPL2009-05-19
44199ORIG2007-06-29
7692SUPPL2006-01-20
38913SUPPL2006-01-13
29979SUPPL2004-06-01