FDA.reportPublic FDA data

Application 203083

Type
ANDA
Sponsor
HETERO LABS LTD III

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
31722-570LansoprazoleLansoprazoleCamber Pharmaceuticals, Inc.ANDACurrent
31722-571LansoprazoleLansoprazoleCamber Pharmaceuticals, Inc.ANDACurrent
68071-2734LansoprazoleLansoprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
82009-039LansoprazoleLansoprazoleQuallent Pharmaceuticals Health LLCANDACurrent
82009-039LansoprazoleLansoprazoleQuallent Pharmaceuticals Health LLCANDACurrent