FDA.reportPublic FDA data

Application 207372

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL75MG;25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-574NitrofurantoinNitrofurantoin monohydrate/macrocrystalsAvKAREANDACurrent
42291-574NitrofurantoinNitrofurantoin monohydrate/macrocrystalsAvKARE, Inc.ANDACurrent
50090-4570NitrofurantoinNitrofurantoin monohydrate/macrocrystalsA-S Medication SolutionsANDACurrent
50090-4570NitrofurantoinNitrofurantoin monohydrate/macrocrystalsA-S Medication SolutionsANDACurrent
50090-4591NitrofurantoinNitrofurantoin monohydrate/macrocrystalsA-S Medication SolutionsANDACurrent
50090-4591NitrofurantoinNitrofurantoin monohydrate/macrocrystalsA-S Medication SolutionsANDACurrent
50268-625NitrofurantoinNitrofurantoin monohydrate/macrocrystalsAvPAKANDACurrent
50268-625NitrofurantoinNitrofurantoin monohydrate/macrocrystalsAvPAKANDACurrent
53002-7042NitrofurantoinNitrofurantoin monohydrate/macrocrystalsRPK Pharmaceuticals, Inc.ANDACurrent
53002-7042NitrofurantoinNitrofurantoin monohydrate/macrocrystalsRPK Pharmaceuticals, Inc.ANDACurrent
55700-794NitrofurantoinNitrofurantoin monohydrate/macrocrystalsQuality Care Products, LLCANDACurrent
55700-794NitrofurantoinNitrofurantoin monohydrate/macrocrystalsQuality Care Products, LLCANDACurrent
60687-633NitrofurantoinNitrofurantoin monohydrate/macrocrystalsAmerican Health PackagingANDACurrent
60760-478NitrofurantoinNitrofurantoin monohydrate/macrocrystalsSt. Mary's Medical Park PharmacyANDACurrent
65162-478NitrofurantoinNitrofurantoin monohydrate/macrocrystalsAmneal Pharmaceuticals LLCANDACurrent
65162-478NitrofurantoinNitrofurantoin monohydrate/macrocrystalsAmneal Pharmaceuticals LLCANDACurrent
65162-478NitrofurantoinNitrofurantoin monohydrate/macrocrystalsAmneal Pharmaceuticals LLCANDACurrent
65162-478NitrofurantoinNitrofurantoin monohydrate/macrocrystalsAmneal Pharmaceuticals LLCANDACurrent
65162-478NitrofurantoinNitrofurantoin monohydrate/macrocrystalsAmneal Pharmaceuticals LLCANDACurrent
67296-1640NitrofurantoinNitrofurantoin monohydrate/macrocrystalsRedPharm Drug, Inc.ANDACurrent
67296-1640NitrofurantoinNitrofurantoin monohydrate/macrocrystalsRedPharm Drug, Inc.ANDACurrent
68071-4531NitrofurantoinNitrofurantoin monohydrate/macrocrystalsNuCare Pharmaceuticals,InANDACurrent
68071-4531NitrofurantoinNitrofurantoin monohydrate/macrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4531NitrofurantoinNitrofurantoin monohydrate/macrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4535Nitrofurantoin monohydrate/macrocrystalsNitrofurantoin monohydrate/macrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4535Nitrofurantoin monohydrate/macrocrystalsNitrofurantoin monohydrate/macrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4535Nitrofurantoin monohydrate/macrocrystalsNitrofurantoin monohydrate/macrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7276NitrofurantoinNitrofurantoin monohydrate/macrocrystalsPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0799NitrofurantoinNitrofurantoin monohydrate/macrocrystalsREMEDYREPACK INC.ANDACurrent
70518-0799NitrofurantoinNitrofurantoin monohydrate/macrocrystalsREMEDYREPACK INC.ANDACurrent
70934-129NitrofurantoinNitrofurantoin monohydrate/macrocrystalsDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-129NitrofurantoinNitrofurantoin monohydrate/macrocrystalsDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-129NitrofurantoinNitrofurantoin monohydrate/macrocrystalsDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0863NitrofurantoinNitrofurantoin monohydrate/macrocrystalsBryant Ranch PrepackANDACurrent
71335-0863NitrofurantoinNitrofurantoin monohydrate/macrocrystalsBryant Ranch PrepackANDACurrent
71335-0863NitrofurantoinNitrofurantoin monohydrate/macrocrystalsBryant Ranch PrepackANDACurrent
71335-0863NitrofurantoinNitrofurantoin monohydrate/macrocrystalsBryant Ranch PrepackANDACurrent