Application 216495

Type
ANDA
Sponsor
ZYDUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATETABLET;ORALEQ 5MG BASENoNo
002PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATETABLET;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1667Prochlorperazine MaleateProchlorperazine MaleateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1668Prochlorperazine MaleateProchlorperazine MaleateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1697Prochlorperazine MaleateProchlorperazine MaleateCadila Healthcare LimitedANDACurrent
70771-1698Prochlorperazine MaleateProchlorperazine MaleateCadila Healthcare LimitedANDACurrent