FDA.report

Application 091672

Type
ANDA
Sponsor
GLENMARK GENERICS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL10MGNoNo
002OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL20MGNoNo
003OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL40MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8079OmeprazoleOmeprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8079OmeprazoleOmeprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8079OmeprazoleOmeprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-972OmeprazoleOmeprazoleBlenheim Pharmacal, Inc.ANDACurrent
45865-966OmeprazoleOmeprazolemedsource pharmaceuticalsANDACurrent
50090-2023OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-2067OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-2769OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-2769OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-3876OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-3876OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-3876OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-5111OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-5501OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50436-0396OmeprazoleOmeprazoleUnit Dose ServicesANDACurrent
50436-0396OmeprazoleOmeprazoleUnit Dose ServicesANDACurrent
60760-396OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
61919-807OMEPRAZOLEOMEPRAZOLEDirexctRXANDACurrent
61919-807OMEPRAZOLEOMEPRAZOLEDirexctRXANDACurrent
61919-807OMEPRAZOLEOMEPRAZOLEDirexctRXANDACurrent
61919-847OMEPRAZOLEOMEPRAZOLEDirect RxANDACurrent
61919-847OMEPRAZOLEOMEPRAZOLEDirect RxANDACurrent
63187-509OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-787OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-787OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-820OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-820OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-820OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-820OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-820OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-820OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-828OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-828OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-828OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-828OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-828OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63629-8108OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
63629-8108OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
63629-8108OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
67296-1615OmeprazoleOmeprazoleRedPharm Drug, Inc.ANDACurrent
67296-1615OmeprazoleOmeprazoleRedPharm Drug, Inc.ANDACurrent
67296-1615OmeprazoleOmeprazoleRedPharm Drug, Inc.ANDACurrent
68071-1522OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1522OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1522OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2199OmeprazoleOmeprazoleNuCarePharmaceuticals, Inc.ANDACurrent
68071-2199OmeprazoleOmeprazoleNuCarePharmaceuticals, Inc.ANDACurrent
68071-2432OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2432OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2442OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2688OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3007OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3007OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4024OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4024OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4024OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-6881OmeprazoleOmeprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-6881OmeprazoleOmeprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-6881OmeprazoleOmeprazolePreferred Pharmaceuticals Inc.ANDACurrent