Application 210625

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEPOWDER;INTRAVENOUSEQ 150MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-299FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEAuroMedics Pharma LLCANDACurrent
55150-299FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEAuroMedics Pharma LLCANDACurrent
55150-299FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEAuroMedics Pharma LLCANDACurrent
55150-299FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEAuroMedics Pharma LLCANDACurrent
59651-523FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEAurobindo Pharma LimitedANDACurrent
82238-018FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINEEUGIA Pharma Specialities LimitedANDACurrent