FDA.report

Application 076048

Type
ANDA
Sponsor
APOTEX

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
0904-5684OmeprazoleOmeprazoleMajor PharmaceuticalsANDACurrent
0904-5684OmeprazoleOmeprazoleMajor PharmaceuticalsANDACurrent
10544-878OmeprazoleOmeprazoleBlenheim Pharmacal, Inc.ANDACurrent
10544-895OmeprazoleOmeprazoleBlenheim Pharmacal, Inc.ANDACurrent
10544-898OmeprazoleOmeprazoleBlenheim Pharmacal, Inc.ANDACurrent
33358-273OmeprazoleOmeprazoleRxChange Co.ANDACurrent
42291-572OmeprazoleOmeprazoleAvKARE, Inc.ANDACurrent
42291-572OmeprazoleOmeprazoleAvKAREANDACurrent
42291-573OmeprazoleOmeprazoleAvKARE, Inc.ANDACurrent
42291-573OmeprazoleOmeprazoleAvKAREANDACurrent
42708-080OmeprazoleOmeprazoleQPharma IncANDACurrent
42708-080OmeprazoleOmeprazoleQPharma IncANDACurrent
42708-080OmeprazoleOmeprazoleQPharma IncANDACurrent
43063-212OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-212OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-212OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-451OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-451OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-451OmeprazoleOmeprazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
48433-327OmeprazoleOmeprazoleSafecor Health, LLCANDACurrent
50436-0065OmeprazoleOmeprazoleUnit Dose ServicesANDACurrent
50436-0146OmeprazoleOmeprazoleUnit Dose ServicesANDACurrent
50436-3127OmeprazoleOmeprazoleUnit Dose ServicesANDACurrent
51655-022OMEPRAZOLEOMEPRAZOLE DRNorthwind Pharmaceuticals, LLCANDACurrent
51655-023OMEPRAZOLEOMEPRAZOLENorthwind Pharmaceuticals, LLCANDACurrent
53808-0745Omeprazole Delayed-ReleaseOMEPRAZOLEDOH CENTRAL PHARMACYANDACurrent
55154-3348OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-3348OmeprazoleOmeprazoleCardinal HealthANDACurrent
58517-020OmeprazoleOmeprazoleNew Horizon Rx Group, LLCANDACurrent
60429-182OmeprazoleOmeprazoleGolden State Medical Supply, Inc.ANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0065OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0145OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-0146OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60505-3952OmeprazoleOmeprazoleApotex CorpANDACurrent
60760-521OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
61919-176OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-176OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-176OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-176OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-773OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-773OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-773OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
61919-773OMEPRAZOLE DROMEPRAZOLE DRDirect RxANDACurrent
63187-061OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-061OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-061OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-070OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-070OmeprazoleOmeprazoleProficient Rx LPANDACurrent