FDA.reportPublic FDA data

Application 204616

Type
ANDA
Sponsor
QILU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS50MG/VIALNoNo
002OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS100MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51991-218OxaliplatinOxaliplatinBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-218OxaliplatinOxaliplatinBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-219OxaliplatinOxaliplatinBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-219OxaliplatinOxaliplatinBreckenridge Pharmaceutical, Inc.ANDACurrent
67184-0501OxaliplatinOxaliplatinQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0501OxaliplatinOxaliplatinQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0501OxaliplatinOxaliplatinQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0502OxaliplatinOxaliplatinQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0502OxaliplatinOxaliplatinQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0502OxaliplatinOxaliplatinQilu Pharmaceutical Co., Ltd.ANDACurrent
79672-018OxaliplatinOXALIPLATINNextgen Pharmaceuticals LLCANDACurrent
79672-019OxaliplatinOXALIPLATINNextgen Pharmaceuticals LLCANDACurrent
79672-825OxaliplatinOXALIPLATINNextgen Pharmaceuticals LLCANDACurrent
79672-825OxaliplatinOXALIPLATINNextgen Pharmaceuticals LLCANDACurrent
79672-826OxaliplatinOXALIPLATINNextgen Pharmaceuticals LLCANDACurrent
79672-826OxaliplatinOXALIPLATINNextgen Pharmaceuticals LLCANDACurrent