FDA.reportPublic FDA data

Application 202960

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATOVAQUONEATOVAQUONESUSPENSION;ORAL750MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-693ATOVAQUONEATOVAQUONEAmneal Pharmaceuticals LLCANDACurrent
65162-693ATOVAQUONEATOVAQUONEAmneal Pharmaceuticals LLCANDACurrent
65162-693ATOVAQUONEATOVAQUONEAmneal Pharmaceuticals LLCANDACurrent
65162-693ATOVAQUONEATOVAQUONEAmneal Pharmaceuticals LLCANDACurrent
65162-693ATOVAQUONEATOVAQUONEAmneal Pharmaceuticals LLCANDACurrent
66689-062AtovaquoneAtovaquoneVistaPharm, Inc.ANDACurrent
66689-062AtovaquoneAtovaquoneVistaPharm, Inc.ANDACurrent
66689-062AtovaquoneAtovaquoneVistaPharm, Inc.ANDACurrent
66689-062AtovaquoneAtovaquoneVistaPharm, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10137ORIG2014-03-20