FDA.reportPublic FDA data

Application 206939

Type
ANDA
Sponsor
BELCHER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFIXIMECEFIXIMEFOR SUSPENSION;ORAL500MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62250-668CefiximecefiximeBelcher Pharmaceuticals,LLCANDACurrent
62250-668CefiximecefiximeBelcher Pharmaceuticals,LLCANDACurrent
62250-668CefiximecefiximeBelcher Pharmaceuticals,LLCANDACurrent
62250-668CefiximecefiximeBelcher Pharmaceuticals,LLCANDACurrent
62250-668CefiximecefiximeBelcher Pharmaceuticals,LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47137ORIG2017-02-08
47132ORIG2017-02-08