FDA.reportPublic FDA data

Application 204299

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;SUBLINGUAL1.75MGNoNo
002ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET;SUBLINGUAL3.5MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-761ZOLPIDEM TARTRATEzolpidem tartrateNovel Laboratories, Inc.ANDACurrent
40032-761ZOLPIDEM TARTRATEzolpidem tartrateNovel Laboratories, Inc.ANDACurrent
40032-762ZOLPIDEM TARTRATEzolpidem tartrateNovel Laboratories, Inc.ANDACurrent
40032-762ZOLPIDEM TARTRATEzolpidem tartrateNovel Laboratories, Inc.ANDACurrent
43386-761ZOLPIDEM TARTRATEzolpidem tartrateLupin Pharmaceuticals,Inc.ANDACurrent
43386-761ZOLPIDEM TARTRATEzolpidem tartrateLupin Pharmaceuticals,Inc.ANDACurrent
43386-761ZOLPIDEM TARTRATEzolpidem tartrateLupin Pharmaceuticals,Inc.ANDACurrent
43386-762ZOLPIDEM TARTRATEzolpidem tartrateLupin Pharmaceuticals,Inc.ANDACurrent
43386-762ZOLPIDEM TARTRATEzolpidem tartrateLupin Pharmaceuticals,Inc.ANDACurrent
43386-762ZOLPIDEM TARTRATEzolpidem tartrateLupin Pharmaceuticals,Inc.ANDACurrent