FDA.reportPublic FDA data

Application 016620

Type
NDA
Sponsor
ALVOGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MACRODANTINNITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL50MGYesNo
002MACRODANTINNITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL100MGYesYes
003MACRODANTINNITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL25MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7136nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsMajor PharmaceuticalsNDACurrent
12634-415Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsApotheca Inc.NDACurrent
33261-226Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsAidarex Pharmaceuticals LLCNDACurrent
43063-400Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsPD-Rx Pharmaceuticals, InNDACurrent
43063-400Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-400Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-400nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-400nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-400nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-400nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-675nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-675nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-675nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsPD-Rx Pharmaceuticals, Inc.NDACurrent
43063-675nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsPD-Rx Pharmaceuticals, Inc.NDACurrent
47781-306nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-306nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-306nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-306nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-306nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-307nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-307nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-307nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-307nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-307nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-308nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-308nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-308nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-308nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
47781-308nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsAlvogen Inc.NDACurrent
50090-0314Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsA-S Medication SolutionsNDACurrent
50436-0308Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsUnit Dose ServicesNDACurrent
52427-286MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma Inc.NDACurrent
52427-286MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma LLCNDACurrent
52427-286MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma Inc.NDACurrent
52427-286MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma LLCNDACurrent
52427-286MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma Inc.NDACurrent
52427-287MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma Inc.NDACurrent
52427-287MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma LLCNDACurrent
52427-287MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma Inc.NDACurrent
52427-287MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma Inc.NDACurrent
52427-287MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma LLCNDACurrent
52427-288MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma LLCNDACurrent
52427-288MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma Inc.NDACurrent
52427-288MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma LLCNDACurrent
52427-288MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma Inc.NDACurrent
52427-288MacrodantinNitrofurantoin macrocrystalsAlmatica Pharma Inc.NDACurrent
55700-295Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsLake Erie Medical DBA Quality Care Products LLCNDACurrent
55700-295Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsLake Erie Medical DBA Quality Care Products LLCNDACurrent
55700-295Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsLake Erie Medical DBA QuaNDACurrent
55700-295Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsLake Erie Medical DBA Quality Care Products LLCNDACurrent
55700-388Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsLake Erie Medical DBA Quality Care Products LLCNDACurrent
61919-458NITROFURANTOIN MACROCRYSTALSnitrofurantoinDIRECT RXNDACurrent
61919-458NITROFURANTOIN MACROCRYSTALSnitrofurantoinDIRECT RXNDACurrent
61919-458NITROFURANTOIN MACROCRYSTALSnitrofurantoinDIRECT RXNDACurrent
63187-245Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsProficient Rx LPNDACurrent
63187-245Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsProficient Rx LPNDACurrent
63187-245Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsProficient Rx LPNDACurrent
63629-6653Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsBryant Ranch PrepackNDACurrent
66267-156Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsNuCare Pharmaceuticals, Inc.NDACurrent
68001-002Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsBluePoint LaboratoriesNDACurrent
68001-003Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsBluePoint LaboratoriesNDACurrent
68084-077Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmerican Health PackagingNDACurrent
68084-077Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmerican Health PackagingNDACurrent
68084-078Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmerican Health PackagingNDACurrent
68084-078Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmerican Health PackagingNDACurrent
68788-6874Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsPreferred Pharmaceuticals Inc.NDACurrent
68788-7806nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsPreferred Pharmaceuticals Inc.NDACurrent
68788-7806nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsPreferred Pharmaceuticals Inc.NDACurrent
68788-7806nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsPreferred Pharmaceuticals Inc.NDACurrent
70518-0103Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsREMEDYREPACK INC.NDACurrent
70518-0103Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsREMEDYREPACK INC.NDACurrent
71205-023Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsProficient Rx LPNDACurrent
71205-023Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsProficient Rx LPNDACurrent
71335-0500Nitrofurantion Macrocrystalsnitrofurantoin macrocrystalsBryant Ranch PrepackNDACurrent
71335-0500Nitrofurantion MacrocrystalsNitrofurantion MacrocrystalsBryant Ranch PrepackNDACurrent
71335-2074nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsBryant Ranch PrepackNDACurrent
76413-144NitrofurantoinNitrofurantion MacrocrystalsCentral Texas Community Health CentersNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68427SUPPL2021-08-20
65960SUPPL2021-01-22
13012SUPPL2013-09-10
10903SUPPL2013-09-09
13011SUPPL2011-06-09
33186SUPPL2009-03-17
467SUPPL2009-03-06
40719SUPPL2008-08-11
20060SUPPL2008-08-11
40720SUPPL2008-08-01
20061SUPPL2008-07-31
40718SUPPL2008-02-19
40717SUPPL2008-02-19
40716SUPPL2008-02-19
20059SUPPL2008-02-19
20058SUPPL2008-02-19
13010SUPPL2007-09-25
33185SUPPL2007-09-19
40714SUPPL2007-07-09
40713SUPPL2007-07-09
20056SUPPL2007-07-09
20055SUPPL2007-07-09
20054SUPPL2007-07-09
20057SUPPL2007-02-20
40715SUPPL2006-05-10
466SUPPL2004-04-07
33184SUPPL2004-04-05
13009SUPPL2003-02-04