FDA.reportPublic FDA data

Application 202176

Type
ANDA
Sponsor
WOCKHARDT USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LANSOPRAZOLELANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL15MGNoNo
002LANSOPRAZOLELANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-669LansoprazoleLansoprazoleWockhardt LimitedANDACurrent
55648-670LansoprazoleLansoprazoleWockhardt LimitedANDACurrent
64679-669LansoprazoleLansoprazoleWockhardt USA LLC.ANDACurrent
64679-669LansoprazoleLansoprazoleWockhardt USA LLC.ANDACurrent
64679-670LansoprazoleLansoprazoleWockhardt USA LLC.ANDACurrent
64679-670LansoprazoleLansoprazoleWockhardt USA LLC.ANDACurrent
68788-8999LansoprazoleLansoprazolePreferred Pharmaceuticals, Inc.ANDACurrent