FDA.reportPublic FDA data

Application 209714

Type
ANDA
Sponsor
HBT LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FULVESTRANTFULVESTRANTINJECTABLE;INTRAMUSCULAR50MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70534-002fulvestrantfulvestrantHBT Labs, Inc.ANDACurrent
70534-002fulvestrantfulvestrantHBT Labs, Inc.ANDACurrent
70534-002fulvestrantfulvestrantHBT Labs, Inc.ANDACurrent
70534-002fulvestrantfulvestrantHBT Labs, Inc.ANDACurrent
70534-002fulvestrantfulvestrantHBT Labs, Inc.ANDACurrent
70534-002fulvestrantfulvestrantHBT Labs, Inc.ANDACurrent
71288-555FulvestrantFulvestrantMeitheal Pharmaceuticals IncANDACurrent
71288-555FulvestrantFulvestrantMeitheal Pharmaceuticals IncANDACurrent
71288-555FulvestrantFulvestrantMeitheal Pharmaceuticals IncANDACurrent
71288-555FulvestrantFulvestrantMeitheal Pharmaceuticals IncANDACurrent
72603-105FulvestrantFulvestrantNorthStar Rx LLCANDACurrent
72603-105FulvestrantFulvestrantNorthStar Rx LLCANDACurrent
72603-105FulvestrantFulvestrantNorthStar Rx LLCANDACurrent
72603-105FulvestrantFulvestrantNorthStar Rx LLCANDACurrent
72603-105FulvestrantFulvestrantNorthStar Rx LLCANDACurrent