FDA.reportPublic FDA data

Application 090973

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSCAPSULE;ORAL1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDSNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6706Omega-3-acid ethyl estersOmega-3-acid ethyl estersMajor PharmaceuticalsANDACurrent
0904-6706Omega-3-acid ethyl estersOmega-3-acid ethyl estersMajor PharmaceuticalsANDACurrent
0904-6706Omega-3-acid ethyl estersOmega-3-acid ethyl estersMajor PharmaceuticalsANDACurrent
42291-657Omega-3-acid ethyl estersOmega-3-acid ethyl estersAvKARE, Inc.ANDACurrent
42291-657Omega-3-acid ethyl estersOmega-3-acid ethyl estersAvKAREANDACurrent
42291-657Omega-3-acid ethyl estersOmega-3-acid ethyl estersAvKAREANDACurrent
50090-3421Omega-3-acid ethyl estersOmega-3-acid ethyl estersA-S Medication SolutionsANDACurrent
50090-3742Omega-3-acid ethyl estersOmega-3-acid ethyl estersA-S Medication SolutionsANDACurrent
50090-3742Omega-3-acid ethyl estersOmega-3-acid ethyl estersA-S Medication SolutionsANDACurrent
50090-3742Omega-3-acid ethyl estersOmega-3-acid ethyl estersA-S Medication SolutionsANDACurrent
55700-873Omega-3-acid ethyl estersOmega-3-acid ethyl estersQuality Care Products, LLCANDACurrent
55700-873Omega-3-acid ethyl estersOmega-3-acid ethyl estersQuality Care Products, LLCANDACurrent
60505-3170Omega-3-acid ethyl estersOmega-3-acid ethyl estersApotex Corp.ANDACurrent
60505-3170Omega-3-acid ethyl estersOmega-3-acid ethyl estersApotex Corp.ANDACurrent
60505-3170Omega-3-acid ethyl estersOmega-3-acid ethyl estersApotex Corp.ANDACurrent
60505-3170Omega-3-acid ethyl estersOmega-3-acid ethyl estersApotex Corp.ANDACurrent
60505-3170Omega-3-acid ethyl estersOmega-3-acid ethyl estersApotex Corp.ANDACurrent
60505-3170Omega-3-acid ethyl estersOmega-3-acid ethyl estersApotex Corp.ANDACurrent
60505-4462Omega-3-acid ethyl estersOmega-3-acid ethyl estersApotex Corp.ANDACurrent
60505-4462Omega-3-acid ethyl estersOmega-3-acid ethyl estersApotex Corp.ANDACurrent
60505-4462Omega-3-acid ethyl estersOmega-3-acid ethyl estersApotex Corp.ANDACurrent
60505-4462Omega-3-acid ethyl estersOmega-3-acid ethyl estersApotex Corp.ANDACurrent
60505-4462Omega-3-acid ethyl estersOmega-3-acid ethyl estersApotex Corp.ANDACurrent
60505-4462Omega-3-acid ethyl estersOmega-3-acid ethyl estersApotex Corp.ANDACurrent
60687-127Omega-3-acid ethyl estersOmega-3-acid ethyl estersAmerican Health PackagingANDACurrent
60687-127Omega-3-acid ethyl estersOmega-3-acid ethyl estersAmerican Health PackagingANDACurrent
60687-127Omega-3-acid ethyl estersOmega-3-acid ethyl estersAmerican Health PackagingANDACurrent
60687-127Omega-3-acid ethyl estersOmega-3-acid ethyl estersAmerican Health PackagingANDACurrent
63629-7015Omega-3-acid ethyl estersOmega-3-acid ethyl estersBryant Ranch PrepackANDACurrent
69176-011Omega-3 Well PackOmega-3 Well PackTMIG, Inc.ANDACurrent
69176-190Omega-3 Rx CompleteOmega-3 Rx CompleteTMIG, Inc.ANDACurrent
69837-170OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSInternational Brand Management IncANDACurrent
69837-700Sure Result O3D3 SystemOMEGA-3-ACID ETHYL ESTERSInternational Brand Management, LLCANDACurrent
70036-015Omega-3 Well PackOmega-3 Well PackCloverleaf Pharma LLCANDACurrent
70518-1636Omega-3-acid ethyl estersOmega-3-acid ethyl estersREMEDYREPACK INC.ANDACurrent
70518-1636Omega-3-acid ethyl estersOmega-3-acid ethyl estersREMEDYREPACK INC.ANDACurrent
70518-1636Omega-3-acid ethyl estersOmega-3-acid ethyl estersREMEDYREPACK INC.ANDACurrent
70518-1636Omega-3-acid ethyl estersOmega-3-acid ethyl estersREMEDYREPACK INC.ANDACurrent
72189-024OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSDirect_RxANDACurrent
72189-024OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSDirect_RxANDACurrent
72189-024OMEGA-3-ACID ETHYL ESTERSOMEGA-3-ACID ETHYL ESTERSDirect_RxANDACurrent