FDA.reportPublic FDA data

Application 204060

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSAMPRENAVIR CALCIUMFOSAMPRENAVIR CALCIUMTABLET;ORALEQ 700MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3520Fosamprenavir Calciumfosamprenavir calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3520Fosamprenavir Calciumfosamprenavir calciumMylan Pharmaceuticals Inc.ANDACurrent
0378-3520Fosamprenavir Calciumfosamprenavir calciumMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
46010ORIG2016-12-02
10289ORIG2016-04-20