FDA.reportPublic FDA data

Application 040700

Type
ANDA
Sponsor
ECR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONEDEXAMETHASONETABLET;ORAL1.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0095-0087DexamethasoneDexamethasoneBausch Health US LLCANDACurrent
0095-0087DexamethasoneDexamethasoneECR PharmaceuticalsANDACurrent
0095-0087DexamethasoneDexamethasoneBausch Health US LLCANDACurrent
0095-0087DexamethasoneDexamethasoneBausch Health Americas, Inc.ANDACurrent
0095-0088DexamethasoneDexamethasoneBausch Health US LLCANDACurrent
0095-0088DexamethasoneDexamethasoneECR PharmaceuticalsANDACurrent
0095-0088DexamethasoneDexamethasoneBausch Health US LLCANDACurrent
0095-0088DexamethasoneDexamethasoneBausch Health Americas, Inc.ANDACurrent
0095-0089DexamethasoneDexamethasoneBausch Health US LLCANDACurrent
0095-0089DexamethasoneDexamethasoneECR PharmaceuticalsANDACurrent
0095-0089DexamethasoneDexamethasoneBausch Health US LLCANDACurrent
0095-0089DexamethasoneDexamethasoneBausch Health Americas, Inc.ANDACurrent