FDA.reportPublic FDA data

Application 078558

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL400MGNoNo
002IBUPROFENIBUPROFENTABLET;ORAL600MGNoNo
003IBUPROFENIBUPROFENTABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-2525IbuprofenIbuprofenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2526IbuprofenIbuprofenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2528IbuprofenIbuprofenNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-014IbuprofenIbuprofenBlenheim Pharmacal, Inc.ANDACurrent
10544-015IbuprofenIbuprofenBlenheim Pharmacal, Inc.ANDACurrent
10544-024IbuprofenIbuprofenBlenheim Pharmacal, Inc.ANDACurrent
10544-030IbuprofenIbuprofenBlenheim Pharmacal, Inc.ANDACurrent
10544-213IbuprofenIbuprofenBlenheim Pharmacal, Inc.ANDACurrent
10544-214IbuprofenIbuprofenBlenheim Pharmacal, Inc.ANDACurrent
10544-613IbuprofenIbuprofenBlenheim Pharmacal, Inc.ANDACurrent
11819-357IbuprofenIbuprofenHHS/Program Support Center/Supply Service CenterANDACurrent
33261-061IbuprofenIbuprofenAidarex Pharmaceuticals LLCANDACurrent
33261-062IbuprofenIbuprofenAidarex Pharmaceuticals LLCANDACurrent
33261-155IbuprofenIbuprofenAidarex Pharmaceuticals LLCANDACurrent
33358-188IbuprofenIbuprofenRxChange Co.ANDACurrent
35356-698IbuprofenIbuprofenLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
42254-034IbuprofenIbuprofenRebel Distributors CorpANDACurrent
42254-063IbuprofenIbuprofenRebel Distributors CorpANDACurrent
42254-089IbuprofenIbuprofenRebel Distributors CorpANDACurrent
42291-337IbuprofenIbuprofenAvKARE, Inc.ANDACurrent
42291-337IbuprofenIbuprofenAvKARE, Inc.ANDACurrent
42291-337IbuprofenIbuprofenAvKARE, Inc.ANDACurrent
42291-337IbuprofenIbuprofenAvKARE, Inc.ANDACurrent
42291-338IbuprofenIbuprofenAvKARE, Inc.ANDACurrent
42291-338IbuprofenIbuprofenAvKARE, Inc.ANDACurrent
42291-338IbuprofenIbuprofenAvKARE, Inc.ANDACurrent
42291-338IbuprofenIbuprofenAvKARE, Inc.ANDACurrent
42291-339IbuprofenIbuprofenAvKARE, Inc.ANDACurrent
42291-339IbuprofenIbuprofenAvKARE, Inc.ANDACurrent
42291-339IbuprofenIbuprofenAvKARE, Inc.ANDACurrent
42291-339IbuprofenIbuprofenAvKARE, Inc.ANDACurrent
42708-029IbuprofenIbuprofenQPharma IncANDACurrent
42708-057IbuprofenIbuprofenQPharma IncANDACurrent
42708-057IbuprofenIbuprofenQPharma IncANDACurrent
43063-013IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-013IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-013IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-013IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-308IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-308IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-352IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-352IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-352IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-352IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-352IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-843IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-843IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-843IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-843IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-843IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-843IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-845IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-845IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-845IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-845IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-845IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-845IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-847IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-847IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-847IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-847IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-847IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-847IbuprofenIbuprofenPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-389IbuprofenIbuprofenAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
43353-389IbuprofenIbuprofenAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
43353-391IbuprofenIbuprofenAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
43353-391IbuprofenIbuprofenAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
43353-393IbuprofenIbuprofenAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
43353-393IbuprofenIbuprofenAphena Pharma Solutions - Tennessee, Inc.ANDACurrent
45865-373IbuprofenIbuprofenMedsource PharmaceuticalsANDACurrent
45865-474IbuprofenIbuprofenMedsource PharmaceuticalsANDACurrent
45865-474IbuprofenIbuprofenMedsource PharmaceuticalsANDACurrent
49999-006IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0060IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-0066IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-2751IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-4367IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50436-4606IbuprofenIbuprofenUnit Dose ServicesANDACurrent
51138-039IbuprofenIbuprofenMed Health Pharma, LLCANDACurrent
51655-035IbuprofenIbuprofenNorthwind Pharmaceuticals, LLCANDACurrent