Application 091363

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLEDRONIC ACIDZOLEDRONIC ACIDINJECTABLE;INTRAVENOUSEQ 5MG BASE/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-331Zoledronic AcidZoledronic AcidDr.Reddy's Laboratories IncANDACurrent
55111-688Zoledronic AcidZoledronic AcidDr.Reddy's Laboratories LtdANDACurrent
55111-688Zoledronic AcidZoledronic AcidDr.Reddy's Laboratories LtdANDACurrent
55111-688Zoledronic AcidZoledronic AcidDr.Reddy's Laboratories LtdANDACurrent
55111-688Zoledronic AcidZoledronic AcidDr.Reddy's Laboratories LtdANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43250ORIG2013-05-02