Application 080515

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CYANOCOBALAMINCYANOCOBALAMININJECTABLE;INJECTION1MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9619CyanocobalamincyanocobalaminHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9619CyanocobalamincyanocobalaminWest-Ward Pharmaceuticals CorpANDACurrent
0143-9620CyanocobalamincyanocobalaminWest-Ward Pharmaceuticals CorpANDACurrent
0143-9620CyanocobalamincyanocobalaminHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9621CyanocobalamincyanocobalaminWest-Ward Pharmaceuticals CorpANDACurrent
0143-9621CyanocobalamincyanocobalaminHikma Pharmaceuticals USA Inc.ANDACurrent
50090-2709CyanocobalamincyanocobalaminA-S Medication SolutionsANDACurrent
50090-2709CyanocobalamincyanocobalaminA-S Medication SolutionsANDACurrent
51662-1394CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1394CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1394CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1394CYANOCOBALAMINCYANOCOBALAMINHF Acquisition Co LLC, DBA HealthFirstANDACurrent
70529-290Vitamin Deficiency Injectable System - B12CyanocobalaminIT3 Medical LLCANDACurrent
70529-290Vitamin Deficiency Injectable System - B12CyanocobalaminIT3 Medical LLCANDACurrent
70529-290Vitamin Deficiency Injectable System - B12CyanocobalaminIT3 Medical LLCANDACurrent
70529-293Vitamin Deficiency SystemCyanocobalaminIT3 Medical LLCANDACurrent
70529-293Vitamin Deficiency SystemCyanocobalaminIT3 Medical LLCANDACurrent
70529-293Vitamin Deficiency SystemCyanocobalaminIT3 Medical LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22636ORIG2003-08-04