FDA.reportPublic FDA data

Application 079224

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
23155-547ONDANSETRONONDANSETRONHeritage PharmaceuticalsANDACurrent
23155-547ONDANSETRONONDANSETRONHeritage Pharmaceuticals Inc d/b/a as Avet Pharmaceuticals IncANDACurrent
23155-547ONDANSETRONONDANSETRONHeritage PharmaceuticalsANDACurrent
23155-547ONDANSETRONONDANSETRONHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-548ONDANSETRONONDANSETRONHeritage Pharmaceuticals Inc d/b/a as Avet Pharmaceuticals IncANDACurrent
23155-548ONDANSETRONONDANSETRONHeritage PharmaceuticalsANDACurrent
23155-548ONDANSETRONONDANSETRONHeritage PharmaceuticalsANDACurrent
23155-548ONDANSETRONONDANSETRONHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
25021-777ondansetronondansetron hydrochlorideSagent PharmaceuticalsANDACurrent
25021-777ondansetronondansetron hydrochlorideSagent PharmaceuticalsANDACurrent
25021-777ondansetronondansetron hydrochlorideSagent PharmaceuticalsANDACurrent
25021-777ondansetronondansetron hydrochlorideSagent PharmaceuticalsANDACurrent
25021-777ondansetronondansetron hydrochlorideSagent PharmaceuticalsANDACurrent
50090-2342ONDANSETRONONDANSETRONA-S Medication SolutionsANDACurrent
67457-440Ondansetron HydrochlorideOndansetronMylan Institutional LLCANDACurrent
67457-440Ondansetron HydrochlorideOndansetronMylan Institutional LLCANDACurrent
67457-440Ondansetron HydrochlorideOndansetronMylan Institutional LLCANDACurrent
67457-440Ondansetron HydrochlorideOndansetronMylan Institutional LLCANDACurrent
67457-440Ondansetron HydrochlorideOndansetronMylan Institutional LLCANDACurrent
68071-4191ONDANSETRONONDANSETRONNuCare Pharmaceuticals,Inc.ANDACurrent
68083-113OndansetronOndansetronGland Pharma LimitedANDACurrent
68083-113OndansetronOndansetronGland Pharma LimitedANDACurrent
68083-113OndansetronOndansetronGland Pharma LimitedANDACurrent
68083-113OndansetronOndansetronGland Pharma LimitedANDACurrent
70518-1422Ondansetronondansetron hydrochlorideREMEDYREPACK INC.ANDACurrent
70860-776Ondansetronondansetron hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-776Ondansetronondansetron hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-776Ondansetronondansetron hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-776Ondansetronondansetron hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-776Ondansetronondansetron hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-776Ondansetronondansetron hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
71872-7069Ondansetronondansetron hydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7069Ondansetronondansetron hydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7138Ondansetron HydrochlorideOndansetronMedical Purchasing Solutions, LLCANDACurrent
71872-7138Ondansetron HydrochlorideOndansetronMedical Purchasing Solutions, LLCANDACurrent
72266-123OndansetronOndansetronFosun Pharma USA Inc.ANDACurrent
72266-123OndansetronOndansetronFosun Pharma USA Inc.ANDACurrent
72266-123OndansetronOndansetronFosun Pharma USA Inc.ANDACurrent
72266-123OndansetronOndansetronFosun Pharma USA Inc.ANDACurrent