FDA.reportPublic FDA data

Application 075877

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERBUTALINE SULFATETERBUTALINE SULFATETABLET;ORAL2.5MGNoNo
002TERBUTALINE SULFATETERBUTALINE SULFATETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-2611TERBUTALINE SULFATETERBUTALINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-2611TERBUTALINE SULFATETERBUTALINE SULFATEImpax GenericsANDACurrent
0115-2611TERBUTALINE SULFATETERBUTALINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-2622TERBUTALINE SULFATETERBUTALINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-2622TERBUTALINE SULFATETERBUTALINE SULFATEImpax GenericsANDACurrent
0115-2622TERBUTALINE SULFATETERBUTALINE SULFATEAmneal Pharmaceuticals of New York LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23779ORIG2011-02-17