FDA.report

Application 073652

Type
ANDA
Sponsor
IMPAX LABS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL100MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsImpax GenericsANDACurrent
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsImpax GenericsANDACurrent
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1645Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLCANDACurrent
0440-1866Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsLiberty Pharmaceuticals, Inc.ANDACurrent
10544-601Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsBlenheim Pharmacal, Inc.ANDACurrent
42254-070Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsRebel Distributors CorpANDACurrent
50268-624Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAvPAKANDACurrent
50268-624Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAvPAKANDACurrent
50268-624Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAvPAKANDACurrent
50436-6591Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsUnit Dose ServicesANDACurrent
60687-316Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmerican Health PackagingANDACurrent
67296-0658Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsRedPharm Drug Inc.ANDACurrent
68071-2517Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4644Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4644Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4681Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2602Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsREMEDYREPACK INC.ANDACurrent
70518-2602Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsREMEDYREPACK INC.ANDACurrent
70518-2602Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsREMEDYREPACK INC.ANDACurrent
70934-217Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-217Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-217Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-297Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsProficient Rx LPANDACurrent
71205-297Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsProficient Rx LPANDACurrent
71205-297Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsProficient Rx LPANDACurrent
71335-1135NitrofurantoinNitrofurantoin MacrocrystalsBryant Ranch PrepackANDACurrent
71335-1135NitrofurantoinNitrofurantoin MacrocrystalsBryant Ranch PrepackANDACurrent
72789-270Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-270Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsPD-Rx Pharmaceuticals, Inc.ANDACurrent