FDA.reportPublic FDA data

Application 020392

Type
NDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYSTAGONCYSTEAMINE BITARTRATECAPSULE;ORALEQ 50MG BASEYesNo
002CYSTAGONCYSTEAMINE BITARTRATECAPSULE;ORALEQ 150MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-9040Cystagoncysteamine bitartrateMylan Pharmaceuticals Inc.NDACurrent
0378-9040Cystagoncysteamine bitartrateMylan Pharmaceuticals Inc.NDACurrent
0378-9040Cystagoncysteamine bitartrateMylan Pharmaceuticals Inc.NDACurrent
0378-9045Cystagoncysteamine bitartrateMylan Pharmaceuticals Inc.NDACurrent
0378-9045Cystagoncysteamine bitartrateMylan Pharmaceuticals Inc.NDACurrent
0378-9045Cystagoncysteamine bitartrateMylan Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24899SUPPL2007-06-14
12531SUPPL2007-06-07
2467SUPPL2004-02-03
24898SUPPL2001-04-11