FDA.reportPublic FDA data

Application 202366

Type
ANDA
Sponsor
ZYDUS HLTHCARE

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
50090-1945lansoprazolelansoprazoleA-S Medication SolutionsANDACurrent
50090-3195lansoprazolelansoprazoleA-S Medication SolutionsANDACurrent
50268-465lansoprazolelansoprazoleAvPAKANDACurrent
50268-465lansoprazolelansoprazoleAvPAKANDACurrent
50268-465lansoprazolelansoprazoleAvPAKANDACurrent
50268-466lansoprazolelansoprazoleAvPAKANDACurrent
50268-466lansoprazolelansoprazoleAvPAKANDACurrent
55700-616lansoprazolelansoprazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-616lansoprazolelansoprazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-544lansoprazolelansoprazoleSt. Mary's Medical Park PharmacyANDACurrent
61919-655LANSOPRAZOLELANSOPRAZOLEDirect RXANDACurrent
61919-890LANSOPRAZOLELANSOPRAZOLEDirect RXANDACurrent
61919-890LANSOPRAZOLELANSOPRAZOLEDirect RXANDACurrent
61919-891LANSOPRAZOLELANSOPRAZOLEDIRECT RXANDACurrent
63629-5632lansoprazolelansoprazoleBryant Ranch PrepackANDACurrent
63629-5632lansoprazolelansoprazoleBryant Ranch PrepackANDACurrent
63629-7552lansoprazolelansoprazoleBryant Ranch PrepackANDACurrent
63629-7552lansoprazolelansoprazoleBryant Ranch PrepackANDACurrent
65841-769lansoprazolelansoprazoleCadila Healthcare LimitedANDACurrent
65841-769lansoprazolelansoprazoleZydus Lifesciences LimitedANDACurrent
65841-769lansoprazolelansoprazoleCadila Healthcare LimitedANDACurrent
65841-769lansoprazolelansoprazoleCadila Healthcare LimitedANDACurrent
65841-770lansoprazolelansoprazoleCadila Healthcare LimitedANDACurrent
65841-770lansoprazolelansoprazoleCadila Healthcare LimitedANDACurrent
65841-770lansoprazolelansoprazoleZydus Lifesciences LimitedANDACurrent
65841-770lansoprazolelansoprazoleCadila Healthcare LimitedANDACurrent
68071-3019lansoprazolelansoprazoleNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3019lansoprazolelansoprazoleNuCare Pharmaceuticals, Inc.ANDACurrent
68382-543lansoprazolelansoprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-543lansoprazolelansoprazoleZydus Pharmaceuticals USA Inc.ANDACurrent
68382-543lansoprazolelansoprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-544lansoprazolelansoprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-544lansoprazolelansoprazoleZydus Pharmaceuticals USA Inc.ANDACurrent
68382-544lansoprazolelansoprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-7385lansoprazolelansoprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7385lansoprazolelansoprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7385lansoprazolelansoprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7385lansoprazolelansoprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-7385lansoprazolelansoprazolePreferred Pharmaceuticals Inc.ANDACurrent
71335-0105lansoprazolelansoprazoleBryant Ranch PrepackANDACurrent
71335-0105lansoprazolelansoprazoleBryant Ranch PrepackANDACurrent