Dasatinib Monohydrate: Package Insert and Label Information

DASATINIB MONOHYDRATE- dasatinib powder
AX Pharmaceutical Corp

Product label

Dasatinib Monohydrate
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DASATINIB MONOHYDRATE
dasatinib monohydrate powder
Product Information
Product Type BULK INGREDIENT Item Code (Source) NDC:62157-776
Route of Administration NOT APPLICABLE DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DASATINIB (DASATINIB ANHYDROUS) DASATINIB 1 g in 1 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62157-776-01 50 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
bulk ingredient for animal drug compounding 02/04/2019
Labeler — AX Pharmaceutical Corp (202924858)
Establishment
Name Address ID/FEI Operations
Mianyang Kangxin Biological Technology Co., Ltd 554405156 manufacture (62157-776)
Establishment
Name Address ID/FEI Operations
AX Pharmaceutical Corp 202924858 relabel (62157-776), repack (62157-776)

Revised: 02/2019 AX Pharmaceutical Corp

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