FDA.reportPublic FDA data

Application 078899

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-654Bromocriptine mesylateBromocriptine mesylateCadila Healthcare LimitedANDACurrent
65841-654Bromocriptine mesylateBromocriptine mesylateZydus Lifesciences LimitedANDACurrent
65841-654Bromocriptine mesylateBromocriptine mesylateCadila Healthcare LimitedANDACurrent
65841-654Bromocriptine mesylateBromocriptine mesylateCadila Healthcare LimitedANDACurrent
68382-110Bromocriptine mesylateBromocriptine mesylateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-110Bromocriptine mesylateBromocriptine mesylateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-110Bromocriptine mesylateBromocriptine mesylateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-110Bromocriptine mesylateBromocriptine mesylateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-110Bromocriptine mesylateBromocriptine mesylateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-110Bromocriptine mesylateBromocriptine mesylateZydus Pharmaceuticals (USA) Inc.ANDACurrent