FDA.reportPublic FDA data

Application 076153

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAMIDRONATE DISODIUMPAMIDRONATE DISODIUMINJECTABLE;INJECTION30MG/10ML (3MG/ML)NoNo
002PAMIDRONATE DISODIUMPAMIDRONATE DISODIUMINJECTABLE;INJECTION90MG/10ML (9MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-4075Pamidronate DisodiumPamidronate DisodiumTeva Parenteral Medicines, Inc.ANDACurrent
0703-4085Pamidronate DisodiumPamidronate DisodiumTeva Parenteral Medicines, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23804ORIG2008-01-07
31089ORIG2003-04-11
31088ORIG2003-04-10