FDA.reportPublic FDA data

Application 207341

Type
ANDA
Sponsor
BPI LABS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLEDRONIC ACIDZOLEDRONIC ACIDINJECTABLE;INTRAVENOUSEQ 4MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54288-100ZOLEDRONIC ACIDZOLEDRONIC ACIDBPI Labs, LLCANDACurrent
54288-100ZOLEDRONIC ACIDZOLEDRONIC ACIDBPI Labs, LLCANDACurrent
54288-100ZOLEDRONIC ACIDZOLEDRONIC ACIDBPI Labs, LLCANDACurrent
54288-100ZOLEDRONIC ACIDZOLEDRONIC ACIDBPI Labs, LLCANDACurrent
54288-100ZOLEDRONIC ACIDZOLEDRONIC ACIDBPI Labs, LLCANDACurrent