Nitrofurantoin Oral Suspension

Brand(s)
Furadantin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Shionogi Inc. (2014-11-12)
Oldest Current Product
1953-12-23
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SUSPENSION\NITROFURANTOIN
FDAOB
ORAL\SUSPENSION\NITROFURANTOIN
SPL Active
ORAL\SUSPENSION\NITROFURANTOIN
SPL Moiety
ORAL\SUSPENSION\NITROFURANTOIN

product(s) by strength(s)

nitrofurantoin 5 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596300450FuradantinNDAShionogi Inc.1953-12-23NITROFURANTOINORALSUSPENSIONNDA0091756bdf87ae-daf1-4912-9d45-e06fa9eaaf1a

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1400320450ANDANovel Laboratories, Inc.2014-09-08NITROFURANTOINORALSUSPENSIONANDA201693499f9dfd-b533-4021-a3ed-308f0f956c79
2433860450ANDAGavis Pharmaceuticals, Llc2015-05-21NITROFURANTOINORALSUSPENSIONANDA20169393c37857-38f1-4e2e-acb8-4846840e3e85
3576640239ANDACaraco Pharmaceutical Laboratories, Ltd.2012-03-04NITROFURANTOINORALSUSPENSIONANDA2013553954bd0b-5ea5-46ff-9c6e-b82ba3cb02b1
4651620689ANDAAmneal Pharmaceuticals2011-03-24NITROFURANTOINORALSUSPENSIONANDA20167911dcea9c-0c62-4153-976b-bd1f8ef1f6d9
5669930471NDA AUTHORIZED GENERICPrasco Laboratories1953-12-23NITROFURANTOINORALSUSPENSIONNDA009175ec23de8c-7f9c-41c6-a251-35181b447b78

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA201355NITROFURANTOINSUN PHARMACEUTICAL INDUSTRIES INC2013-08-14ANDA201355_001
2ANDA201679NITROFURANTOINAMNEAL PHARMACEUTICALS2011-05-11ANDA201679_001
3ANDA201693NITROFURANTOINNOVEL LABORATORIES INC2014-09-08ANDA201693_001
4NDA009175FURADANTINSHIONOGI INCNDA009175_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA201355_001RXNITROFURANTOIN (25MG/5ML)ORALSUSPENSIONFalseAB2013-08-14NITROFURANTOIN
2ANDA201679_001RXNITROFURANTOIN (25MG/5ML)ORALSUSPENSIONFalseAB2011-05-11NITROFURANTOIN
3ANDA201693_001RXNITROFURANTOIN (25MG/5ML)ORALSUSPENSIONFalseAB2014-09-08NITROFURANTOIN
4NDA009175_001RXNITROFURANTOIN (25MG/5ML)ORALSUSPENSIONTrueABFURADANTIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
111dcea9c-0c62-4153-976b-bd1f8ef1f6d9 (view SPL)Nitrofurantoin Oral Suspension USP, 25 mg/5 mLprescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-01-166651620689
23954bd0b-5ea5-46ff-9c6e-b82ba3cb02b1 (view SPL)Nitrofurantoin Oral Suspension, USPFOR ORAL USE ONLYRx OnlyprescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.ANALYSIS, MANUFACTURE, PACK2014-03-205576640239
3499f9dfd-b533-4021-a3ed-308f0f956c79 (view SPL)Nitrofurantoin Oral Suspension, USPprescriptionHuman PrescriptionNovel Laboratories, Inc.ANALYSIS, MANUFACTURE2014-09-194400320450
46bdf87ae-daf1-4912-9d45-e06fa9eaaf1a (view SPL)Furadantin (nitrofurantoin) Oral SuspensionprescriptionHuman PrescriptionShionogi Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-11-1213596300450
593c37857-38f1-4e2e-acb8-4846840e3e85 (view SPL)Nitrofurantoin Oral Suspension, USP GAVIS Pharmaceuticals, LLCprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2015-06-091433860450
6ec23de8c-7f9c-41c6-a251-35181b447b78 (view SPL)Nitrofurantoin Oral SuspensionprescriptionHuman PrescriptionPrasco LaboratoriesAPI MANUFACTURE2015-03-164669930471

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII