FDA.reportPublic FDA data

Application 202312

Type
ANDA
Sponsor
GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21130-358IbuprofenIbuprofenBETTER LIVING BRANDS LLC.ANDACurrent
21130-358IbuprofenIbuprofenBETTER LIVING BRANDS LLC.ANDACurrent
21130-359IbuprofenIbuprofenBETTER LIVING BRANDS LLC.ANDACurrent
36800-286IbuprofenIbuprofenTOPCO ASSOCIATES LLCANDACurrent
41163-116IbuprofenIbuprofenSUPERVALU INC.ANDACurrent
41163-312ibuprofenIbuprofenSUPERVALU INC.ANDACurrent
49035-684equate ibuprofenibuprofenWal-Mart Stores IncANDACurrent
49035-684equate ibuprofenibuprofenWal-Mart Stores IncANDACurrent
53185-381Ibuprofen 200mgIbuprofen 200mgAthlete's Needs, Inc.ANDACurrent
53185-381Ibuprofen 200mgIbuprofen 200mgAthlete's Needs, Inc.ANDACurrent
53185-381Ibuprofen 200mgIbuprofen 200mgAthlete's Needs, Inc.ANDACurrent
53943-111ibuprofenIbuprofenDISCOUNT DRUG MARTANDACurrent
53943-112IbuprofenIbuprofenDISCOUNT DRUG MARTANDACurrent
55319-358IbuprofenIbuprofenFAMILY DOLLARANDACurrent
55319-398IbuprofenIbuprofenFAMILY DOLLARANDACurrent
55319-398IbuprofenIbuprofenFAMILY DOLLARANDACurrent
57344-811IbuprofenIbuprofenAAA PHARMACEUTICAL, INC.ANDACurrent
62207-320IBUPROFENIBUPROFENGranules India LimitedANDACurrent
62207-320IBUPROFENIBUPROFENGranules India LimitedANDACurrent
62207-320IBUPROFENIBUPROFENGranules India LimitedANDACurrent
62207-321IBUPROFENIBUPROFENGranules India LimitedANDACurrent
62207-321IBUPROFENIBUPROFENGranules India LimitedANDACurrent
62207-321IBUPROFENIBUPROFENGranules India LimitedANDACurrent
62207-357IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-357IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-357IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-358IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-358IbuprofenIbuprofenGranules India LimitedANDACurrent
62207-358IbuprofenIbuprofenGranules India LimitedANDACurrent
63868-570IbuprofenIbuprofenCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-571IbuprofenIbuprofenCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63941-111IbuprofenIbuprofenVALU MERCHANDISERS COMPANYANDACurrent
63941-301IbuprofenIbuprofenVALU MERCHANDISERS COMPANYANDACurrent
67091-368Ibuprofen IBIbuprofenWINCO FOODS, LLCANDACurrent
67091-369Ibuprofen IBIbuprofenWINCO FOODS, LLCANDACurrent
68210-0011Assured IbuprofenIbuprofenSpirit Pharmaceuticals LLCANDACurrent
68210-0011Assured IbuprofenIbuprofenSpirit Pharmaceuticals LLCANDACurrent
68210-0011Assured IbuprofenIbuprofenSpirit Pharmaceuticals LLCANDACurrent
68210-0011Assured IbuprofenIbuprofenSpirit Pharmaceuticals LLCANDACurrent
68210-0011Assured IbuprofenIbuprofenSpirit Pharmaceuticals LLCANDACurrent
68210-4139Assured IbuprofenIbuprofenSpirit Pharmaceuticals LLCANDACurrent
68210-4139Assured IbuprofenIbuprofenSpirit Pharmaceuticals LLCANDACurrent
68210-4139Assured IbuprofenIbuprofenSpirit Pharmaceuticals LLCANDACurrent
68998-011IbuprofenIbuprofenMARC GLASSMAN, INC.ANDACurrent
68998-012IbuprofenIbuprofenMARC GLASSMAN, INC.ANDACurrent
72036-211IbuprofenIbuprofenHarris TeeterANDACurrent
72036-212IbuprofenIbuprofenHarris TeeterANDACurrent
72476-111IbuprofenIbuprofenRETAIL BUSINESS SERVICES , LLC.ANDACurrent
72476-112IBUPROFENIbuprofenRETAIL BUSINESS SERVICES , LLC.ANDACurrent
72476-358IbuprofenIbuprofenRETAIL BUSINESS SERVICES,LLC.ANDACurrent