FDA.reportPublic FDA data

Application 075547

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THIOTEPATHIOTEPAINJECTABLE;INJECTION15MG/VIALNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9309ThiotepaThiotepaWest-Ward PharmaceuticalsANDACurrent
0143-9309ThiotepaThiotepaHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9565ThiotepaThiotepaWest-Ward PharmaceuticalsANDACurrent
0143-9565ThiotepaThiotepaHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9565ThiotepaThiotepaHikma Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39488SUPPL2015-07-30
30929SUPPL2015-07-30
22482ORIG2001-12-17
39487ORIG2001-04-02
8714ORIG2001-04-02