FDA.reportPublic FDA data

Application 040802

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEINJECTABLE;INJECTIONEQ 10MG PHOSPHATE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9842Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateHenry Schein, Inc.ANDACurrent
0404-9842Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateHenry Schein, Inc.ANDACurrent
52584-420Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-420Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-420Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-420Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-420Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateGeneral Injectables and Vaccines, Inc.ANDACurrent
67457-420Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMylan Institutional LLCANDACurrent
67457-483Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMylan Institutional LLCANDACurrent
71872-7090Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMedical Purchasing Solutions, LLCANDACurrent
71872-7090Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMedical Purchasing Solutions, LLCANDACurrent