FDA.reportPublic FDA data

Application 076711

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-5445Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5445Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5445Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5445Bupropion HydrochlorideBUPROPION HYDROCHLORIDEImpax GenericsANDACurrent
0115-5445Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5445Bupropion HydrochlorideBUPROPION HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44318ORIG2005-07-28