FDA.reportPublic FDA data

Application 212977

Type
ANDA
Sponsor
XIROMED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL10MGNoNo
002OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL20MGNoNo
003OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8406OmeprazoleOmeprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8406OmeprazoleOmeprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
50090-5901OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-5902OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-5903OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
51407-641OmeprazoleOmeprazoleGolden State Medical Supply, Inc.ANDACurrent
51407-641OmeprazoleOmeprazoleGolden State Medical Supply, Inc.ANDACurrent
70518-3278OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-3278OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-3278OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
71205-613OmeprazoleOmeprazoleProficient Rx LPANDACurrent
71205-613OmeprazoleOmeprazoleProficient Rx LPANDACurrent
71205-613OmeprazoleOmeprazoleProficient Rx LPANDACurrent
71205-907OmeprazoleOmeprazoleProficient Rx LPANDACurrent
71205-907OmeprazoleOmeprazoleProficient Rx LPANDACurrent
71610-663OmeprazoleOmeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-663OmeprazoleOmeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-663OmeprazoleOmeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent