FDA.reportPublic FDA data

Application 212416

Type
ANDA
Sponsor
CUSTOPHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CALCITONIN-SALMONCALCITONIN SALMONINJECTABLE;INJECTION200 IU/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24201-400Calcitonin Salmoncalcitonin salmonLeucadia PharmaceuticalsANDACurrent
24201-400Calcitonin Salmoncalcitonin salmonHikma Pharmaceuticals USA Inc.(dba Leucadia Pharmaceuticals)ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67813ORIG2021-06-15