FDA.reportPublic FDA data

Application 208850

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL5MGNoNo
002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL10MGNoNo
003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL20MGNoNo
004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMTABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1146RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1146RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1146RosuvastatinRosuvastatinAmneal Pharmaceuticals LLCANDACurrent
69238-1146RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1146RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1146RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1147RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1147RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1147RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1147RosuvastatinRosuvastatinAmneal Pharmaceuticals LLCANDACurrent
69238-1147RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1147RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1148RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1148RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1148RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1148RosuvastatinRosuvastatinAmneal Pharmaceuticals LLCANDACurrent
69238-1148RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1148RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1149RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1149RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1149RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1149RosuvastatinRosuvastatinAmneal Pharmaceuticals LLCANDACurrent
69238-1149RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1149RosuvastatinRosuvastatinAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54792ORIG2018-07-06