FDA.reportPublic FDA data

Application 020064

Type
NDA
Sponsor
ALVOGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MACROBIDNITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL75MG;25MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-086Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineBlenheim Pharmacal, Inc.NDACurrent
33261-160Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineAidarex Pharmaceuticals LLCNDACurrent
42254-064Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineRebel Distributors CorpNDACurrent
43063-582Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-582Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-582Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-582Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-582Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-582Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-582Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
47781-303Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineAlvogen Inc.NDACurrent
47781-303Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineAlvogen Inc.NDACurrent
47781-303Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineAlvogen Inc.NDACurrent
47781-303Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineAlvogen Inc.NDACurrent
47781-303Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineAlvogen Inc.NDACurrent
50090-0865Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineA-S Medication SolutionsNDACurrent
50090-0865Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineA-S Medication SolutionsNDACurrent
50090-0865Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineA-S Medication SolutionsNDACurrent
50090-0866Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineA-S Medication SolutionsNDACurrent
50090-0866Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineA-S Medication SolutionsNDACurrent
50090-0866Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineA-S Medication SolutionsNDACurrent
50090-0866Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineA-S Medication SolutionsNDACurrent
50090-4429Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineA-S Medication SolutionsNDACurrent
50436-6590Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineUnit Dose ServicesNDACurrent
51655-611NitrofurantoinNitrofurantoinNorthwind Pharmaceuticals, LLCNDACurrent
52427-285MacrobidNitrofurantoin Monohydrate/MacrocrystallineAlmatica Pharma LLCNDACurrent
52427-285MacrobidNitrofurantoin Monohydrate/MacrocrystallineAlmatica Pharma Inc.NDACurrent
52427-285MacrobidNitrofurantoin Monohydrate/MacrocrystallineAlmatica Pharma Inc.NDACurrent
52427-285MacrobidNitrofurantoin Monohydrate/MacrocrystallineAlmatica Pharma LLCNDACurrent
52427-285MacrobidNitrofurantoin Monohydrate/MacrocrystallineAlmatica Pharma Inc.NDACurrent
52959-783NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINENITROFURANTOIN MONOHYDRATEH.J. Harkins Company, Inc.NDACurrent
53002-7040Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineRPK Pharmaceuticals, Inc.NDACurrent
53002-7040Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineRPK Pharmaceuticals, Inc.NDACurrent
54348-849Nitrofurantoin MonoNITROFURANTOIN MONOHYDRATEPharmPak, Inc.NDACurrent
54348-849Nitrofurantoin MonoNITROFURANTOIN MONOHYDRATEPharmPak, Inc.NDACurrent
55289-822Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-822Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-822Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-822Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-822Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-822Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-822Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-822Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePD-Rx Pharmaceuticals, Inc.NDACurrent
55700-532Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineLake Erie Medical DBA Quality Care Products LLCNDACurrent
60760-055Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineSt. Mary's Medical Park PharmacyNDACurrent
61919-021NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINENITROFURANTOIN MONOHYDRATEDIRECT RXNDACurrent
61919-021NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINENITROFURANTOIN MONOHYDRATEDirect_RxNDACurrent
61919-021NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINENITROFURANTOIN MONOHYDRATEDirect_RxNDACurrent
61919-021NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINENITROFURANTOIN MONOHYDRATEDirect_RxNDACurrent
61919-021NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINENITROFURANTOIN MONOHYDRATEDIRECT RXNDACurrent
61919-021NITROFURANTOIN MONOHYDRATE MACROCRYSTALLINENITROFURANTOIN MONOHYDRATEDirect_RxNDACurrent
63187-263Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineProficient Rx LPNDACurrent
63187-263Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineProficient Rx LPNDACurrent
63187-263Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineProficient Rx LPNDACurrent
63187-263Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineProficient Rx LPNDACurrent
63629-6777Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoinBryant Ranch PrepackNDACurrent
63629-6777Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineBryant Ranch PrepackNDACurrent
67296-0737Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ MacrocrystallineRedPharm Drug, Inc.NDACurrent
67296-0737Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ MacrocrystallineRedPharm Drug, Inc.NDACurrent
67296-0737Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/ MacrocrystallineRedPharm Drug, Inc.NDACurrent
68001-001Nitrofurantoin Monohydrate/MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineBluePoint LaboratoriesNDACurrent
68001-001Nitrofurantoin Monohydrate/MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineBluePoint LaboratoriesNDACurrent
68001-001Nitrofurantoin Monohydrate/MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineBluePoint LaboratoriesNDACurrent
68071-1909Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineNuCare Pharmaceuticals, Inc.NDACurrent
68071-2550Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineNuCare Pharmaceuticals,Inc.NDACurrent
68071-2575Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineNuCare Pharmaceuticals,Inc.NDACurrent
68071-3163Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineNuCare Pharmaceuticals, Inc.NDACurrent
68788-0518Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePreferred Pharmaceuticals, Inc.NDACurrent
68788-0518Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePreferred Pharmaceuticals, Inc.NDACurrent
68788-0518Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallinePreferred Pharmaceuticals, Inc.NDACurrent
70518-0265Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineREMEDYREPACK INC.NDACurrent
70518-0265Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineREMEDYREPACK INC.NDACurrent
70518-0265Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineREMEDYREPACK INC.NDACurrent
70518-0265Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineREMEDYREPACK INC.NDACurrent
70518-0265Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineREMEDYREPACK INC.NDACurrent
70518-0265Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineREMEDYREPACK INC.NDACurrent
70518-0265Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineREMEDYREPACK INC.NDACurrent
70518-0265Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineREMEDYREPACK INC.NDACurrent
70518-0265Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineREMEDYREPACK INC.NDACurrent
70518-0265Nitrofurantoin Monohydrate/ MacrocrystallineNitrofurantoin Monohydrate/MacrocrystallineREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73696SUPPL 2023-03-07
67590SUPPL2021-05-25
65961SUPPL2021-01-22
21088SUPPL2013-09-11
34222SUPPL2013-09-09
1962SUPPL2011-06-09
34221SUPPL2009-03-17
1961SUPPL2009-03-06
1960SUPPL2007-07-05
34220SUPPL2003-11-05
1959SUPPL2003-11-05
21087SUPPL2003-02-04