FDA.reportPublic FDA data

Application 077226

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BROMOCRIPTINE MESYLATEBROMOCRIPTINE MESYLATECAPSULE;ORALEQ 5MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-7096Bromocriptine Mesylatebromocriptine mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-7096Bromocriptine Mesylatebromocriptine mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-7096Bromocriptine Mesylatebromocriptine mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-7096Bromocriptine Mesylatebromocriptine mesylateMylan Pharmaceuticals IncANDACurrent
0378-7096Bromocriptine Mesylatebromocriptine mesylateMylan Pharmaceuticals Inc.ANDACurrent
0378-7096Bromocriptine Mesylatebromocriptine mesylateMylan Pharmaceuticals Inc.ANDACurrent