FDA.reportPublic FDA data

Application 207325

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS50MG/10ML (5MG/ML)NoNo
002OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS100MG/20ML (5MG/ML)NoNo
003OXALIPLATINOXALIPLATININJECTABLE;INTRAVENOUS200MG/40ML (5MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-591OxaliplatinoxaliplatinAlvogen Inc.ANDACurrent
47781-592OxaliplatinoxaliplatinAlvogen Inc.ANDACurrent
51991-922OxaliplatinOxaliplatinBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-923OxaliplatinOxaliplatinBreckenridge Pharmaceutical, Inc.ANDACurrent
68083-176OxaliplatinOxaliplatinGland Pharma LimitedANDACurrent
68083-176OxaliplatinOxaliplatinGland Pharma LimitedANDACurrent
68083-176OxaliplatinOxaliplatinGland Pharma LimitedANDACurrent
68083-177OxaliplatinOxaliplatinGland Pharma LimitedANDACurrent
68083-177OxaliplatinOxaliplatinGland Pharma LimitedANDACurrent
68083-177OxaliplatinOxaliplatinGland Pharma LimitedANDACurrent
68083-314OxaliplatinOxaliplatinGland Pharma LimitedANDACurrent
68083-314OxaliplatinOxaliplatinGland Pharma LimitedANDACurrent
68083-314OxaliplatinOxaliplatinGland Pharma LimitedANDACurrent
70860-201OxaliplatinoxaliplatinAthenex Pharmaceutical Division, LLC.ANDACurrent
71288-101OxaliplatinOxaliplatinMeitheal Pharmaceuticals Inc.ANDACurrent
71288-101OxaliplatinOxaliplatinMeitheal Pharmaceuticals Inc.ANDACurrent
71288-101OxaliplatinOxaliplatinMeitheal Pharmaceuticals Inc.ANDACurrent
71288-149OxaliplatinOxaliplatinMeitheal Pharmaceuticals Inc.ANDACurrent
71288-149OxaliplatinOxaliplatinMeitheal Pharmaceuticals Inc.ANDACurrent
72266-125OxaliplatinOxaliplatinFosun Pharma USA Inc.ANDACurrent
72266-125OxaliplatinOxaliplatinFosun Pharma USA Inc.ANDACurrent
72266-125OxaliplatinOxaliplatinFosun Pharma USA Inc.ANDACurrent
72266-126OxaliplatinOxaliplatinFosun Pharma USA Inc.ANDACurrent
72266-126OxaliplatinOxaliplatinFosun Pharma USA Inc.ANDACurrent
72266-126OxaliplatinOxaliplatinFosun Pharma USA Inc.ANDACurrent
72266-161OxaliplatinOxaliplatinFOSUN PHARMA USA INC.ANDACurrent
72266-161OxaliplatinOxaliplatinFosun Pharma USA Inc.ANDACurrent
72266-162OxaliplatinOxaliplatinFosun Pharma USA Inc.ANDACurrent
72266-162OxaliplatinOxaliplatinFOSUN PHARMA USA INC.ANDACurrent
72603-101OxaliplatinOxaliplatinNorthStar Rx LLCANDACurrent
72603-101OxaliplatinOxaliplatinNorthStar Rx LLCANDACurrent
72603-101OxaliplatinOxaliplatinNorthStar Rx LLCANDACurrent
72603-301OxaliplatinOxaliplatinNorthStar Rx LLCANDACurrent
72603-301OxaliplatinOxaliplatinNorthStar Rx LLCANDACurrent
72603-301OxaliplatinOxaliplatinNorthStar Rx LLCANDACurrent