FDA.reportPublic FDA data

Application 202300

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENCAPSULE;ORALEQ 200MG FREE ACID AND POTASSIUM SALTNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
30142-121IbuprofenIbuprofenThe Kroger Co.ANDACurrent
30142-122IbuprofenIbuprofenThe Kroger Co.ANDACurrent
30142-123IbuprofenIbuprofenThe Kroger Co.ANDACurrent
37808-221IbuprofenIbuprofenH E BANDACurrent
37808-221IbuprofenIbuprofenH E BANDACurrent
37808-221IbuprofenIbuprofenH E BANDACurrent
41250-221IbuprofenIbuprofenMEIJER, INC.ANDACurrent
41250-221IbuprofenIbuprofenMEIJER, INC.ANDACurrent
49035-121IbuprofenIbuprofenEQUATE (Walmart Stores, Inc.)ANDACurrent
49035-121IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
55910-830IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-830IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-830IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
56062-121IbuprofenIbuprofenPublix Supermarkets, Inc.ANDACurrent
56062-121IbuprofenIbuprofenPublix Supermarkets, Inc.ANDACurrent
56062-122IbuprofenIbuprofenPublix Supermarkets, Inc.ANDACurrent
56062-122IbuprofenIbuprofenPublix Supermarkets, Inc.ANDACurrent
63941-121IbuprofenIbuprofenValu Merchandisers Company (Best Choice)ANDACurrent
63981-121IbuprofenIbuprofenCostco WholesaleANDACurrent
63981-121IbuprofenIbuprofenCostco WholesaleANDACurrent
63981-121IbuprofenIbuprofenCostco WholesaleANDACurrent
65162-356IbuprofenIbuprofenAmneal Pharmaceuticals LLCANDACurrent
65162-356IbuprofenIbuprofenAmneal Pharmaceuticals LLCANDACurrent
65162-356IbuprofenIbuprofenAmneal Pharmaceuticals LLCANDACurrent
65162-356IbuprofenIbuprofenAmneal Pharmaceuticals LLCANDACurrent
65162-770Ibuprofen Pain Reliever/Fever ReducerIbuprofenAmneal Pharmaceuticals LLCANDACurrent
65162-770Ibuprofen Pain Reliever/Fever ReducerIbuprofenAmneal Pharmaceuticals LLCANDACurrent
65162-770Ibuprofen Pain Reliever/Fever ReducerIbuprofenAmneal Pharmaceuticals LLCANDACurrent
65162-770Ibuprofen Pain Reliever/Fever ReducerIbuprofenAmneal Pharmaceuticals LLCANDACurrent
68391-121IbuprofenIbuprofenBJWC (Berkley & Jensen / BJ's)ANDACurrent