Application 060716

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POLYMYXIN B SULFATEPOLYMYXIN B SULFATEINJECTABLE;INJECTIONEQ 500,000 UNITS BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9941Polymyxin BPolymyxin B sulfateHikma Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18305SUPPL2015-03-23
18304SUPPL2012-07-30