FDA.reportPublic FDA data

Application 090648

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 2MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-549ONDANSETRONONDANSETRONHeritage PharmaceuticalsANDACurrent
23155-549ONDANSETRONONDANSETRONHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-549ONDANSETRONONDANSETRONHeritage PharmaceuticalsANDACurrent
23155-549ONDANSETRONONDANSETRONHeritage Pharmaceuticals Inc d/b/a as Avet Pharmaceuticals IncANDACurrent
23155-550ONDANSETRONONDANSETRONHeritage Pharmaceuticals Inc d/b/a as Avet Pharmaceuticals IncANDACurrent
23155-550ONDANSETRONONDANSETRONHeritage PharmaceuticalsANDACurrent
23155-550ONDANSETRONONDANSETRONHeritage PharmaceuticalsANDACurrent
23155-550ONDANSETRONONDANSETRONHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
25021-782ondansetronondansetron hydrochlorideSagent PharmaceuticalsANDACurrent
25021-782ondansetronondansetron hydrochlorideSagent PharmaceuticalsANDACurrent
25021-782ondansetronondansetron hydrochlorideSagent PharmaceuticalsANDACurrent
67457-441Ondansetron HydrochlorideOndansetronMylan Institutional LLCANDACurrent
67457-441Ondansetron HydrochlorideOndansetronMylan Institutional LLCANDACurrent
67457-441Ondansetron HydrochlorideOndansetronMylan Institutional LLCANDACurrent
67457-441Ondansetron HydrochlorideOndansetronMylan Institutional LLCANDACurrent
68083-114OndansetronOndansetronGland Pharma LimitedANDACurrent
68083-114OndansetronOndansetronGland Pharma LimitedANDACurrent
68083-114OndansetronOndansetronGland Pharma LimitedANDACurrent
68083-114OndansetronOndansetronGland Pharma LimitedANDACurrent
70518-2895ONDANSETRONONDANSETRONREMEDYREPACK INC.ANDACurrent
70518-2895ONDANSETRONONDANSETRONREMEDYREPACK INC.ANDACurrent
70860-777Ondansetronondansetron hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-777Ondansetronondansetron hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-777Ondansetronondansetron hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-777Ondansetronondansetron hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-777Ondansetronondansetron hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-777Ondansetronondansetron hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
72266-124OndansetronOndansetronFosun Pharma USA Inc.ANDACurrent
72266-124OndansetronOndansetronFosun Pharma USA Inc.ANDACurrent
72266-124OndansetronOndansetronFosun Pharma USA Inc.ANDACurrent
72266-124OndansetronOndansetronFosun Pharma USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22713ORIG2013-01-22