FDA.reportPublic FDA data

Application 091095

Type
ANDA
Sponsor
ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL25MGNoNo
002NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL50MGNoNo
003NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-2023NitrofurantoinNitrofurantoinAmneal Pharmaceuticals of New York LLCANDACurrent
0115-2024NitrofurantoinNitrofurantoinAmneal Pharmaceuticals of New York LLCANDACurrent
0591-3684NitrofurantoinNitrofurantoinActavis Pharma, Inc.ANDACurrent
0591-3684NitrofurantoinNitrofurantoinActavis Pharma, Inc.ANDACurrent
0591-3685NitrofurantoinNitrofurantoinActavis Pharma, Inc.ANDACurrent
0591-3685NitrofurantoinNitrofurantoinActavis Pharma, Inc.ANDACurrent
0591-3686NitrofurantoinNitrofurantoinActavis Pharma, Inc.ANDACurrent
0591-3686NitrofurantoinNitrofurantoinActavis Pharma, Inc.ANDACurrent
68071-2281NitrofurantoinNitrofurantoinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2281NitrofurantoinNitrofurantoinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5050NitrofurantoinNitrofurantoinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5050NitrofurantoinNitrofurantoinNuCare Pharmaceuticals,Inc.ANDACurrent
71205-365NitrofurantoinNitrofurantoinProficient Rx LPANDACurrent
71205-370NitrofurantoinNitrofurantoinProficient Rx LPANDACurrent
71205-370NitrofurantoinNitrofurantoinProficient Rx LPANDACurrent
71205-370NitrofurantoinNitrofurantoinProficient Rx LPANDACurrent
71335-0878NitrofurantoinNitrofurantoinBryant Ranch PrepackANDACurrent
71335-0878NitrofurantoinNitrofurantoinBryant Ranch PrepackANDACurrent
71335-0878NitrofurantoinNitrofurantoinBryant Ranch PrepackANDACurrent
71335-1374NitrofurantoinNitrofurantoinBryant Ranch PrepackANDACurrent