FDA.reportPublic FDA data

Application 203481

Type
ANDA
Sponsor
BRECKENRIDGE

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
51407-129OMEPRAZOLEOMEPRAZOLEGolden State Medical Supply, Inc.ANDACurrent
51407-129OMEPRAZOLEOMEPRAZOLEGolden State Medical SupplyANDACurrent
51407-129OMEPRAZOLEOMEPRAZOLEGolden State Medical SupplyANDACurrent
51407-129OMEPRAZOLEOMEPRAZOLEGolden State Medical SupplyANDACurrent
51407-129OMEPRAZOLEOMEPRAZOLEGolden State Medical SupplyANDACurrent
51407-129OMEPRAZOLEOMEPRAZOLEGolden State Medical Supply Inc.ANDACurrent
51407-130OMEPRAZOLEOMEPRAZOLEGolden State Medical SupplyANDACurrent
51407-130OMEPRAZOLEOMEPRAZOLEGolden State Medical SupplyANDACurrent
51407-130OMEPRAZOLEOMEPRAZOLEGolden State Medical SupplyANDACurrent
51407-130OMEPRAZOLEOMEPRAZOLEGolden State Medical SupplyANDACurrent
51407-130OMEPRAZOLEOMEPRAZOLEGolden State Medical Supply, Inc.ANDACurrent
51407-130OMEPRAZOLEOMEPRAZOLEGolden State Medical Supply Inc.ANDACurrent
51991-642OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-642OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-642OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-642OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-643OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-643OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-643OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-643OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-643OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-643OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-644OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-644OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-644OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-644OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-644OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-644OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-644OMEPRAZOLEOMEPRAZOLEBreckenridge Pharmaceutical, Inc.ANDACurrent
55700-693OMEPRAZOLEOMEPRAZOLEQuality Care Products, LLCANDACurrent
68788-7896OMEPRAZOLEOMEPRAZOLEPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7898OMEPRAZOLEOMEPRAZOLEPreferred Pharmaceuticals Inc.ANDACurrent
70934-433OMEPRAZOLEOMEPRAZOLEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-433OMEPRAZOLEOMEPRAZOLEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-433OMEPRAZOLEOMEPRAZOLEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-433OMEPRAZOLEOMEPRAZOLEDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-959OMEPRAZOLEOMEPRAZOLEProficient Rx LPANDACurrent
71205-960OMEPRAZOLEOMEPRAZOLEProficient Rx LPANDACurrent
71610-297OMEPRAZOLEOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-326OMEPRAZOLEOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCANDACurrent