Fluorouracil Topical Solution

Brand(s)
Efudex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Solco Healthcare U.S., Llc (2010-05-24)
Oldest Current Product
2003-11-05
License(s)
NDA, ANDA
RxNORM
TOPICAL SOLUTION\FLUOROURACIL
FDAOB
TOPICAL\CREAM\FLUOROURACIL
TOPICAL\SOLUTION\FLUOROURACIL
SPL Active
TOPICAL\SOLUTION\FLUOROURACIL
SPL Moiety
TOPICAL\SOLUTION\FLUOROURACIL

product(s) by strength(s)

fluorouracil 20 mg/ml topical solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1435470259NDASolco Healthcare U.S., Llc2010-06-01FLUOROURACILTOPICALSOLUTIONNDA016831e4acd6ec-d981-4756-9c59-7ee981be9c12

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724062ANDATaro Pharmaceuticals U.S.A., Inc.2003-11-05FLUOROURACILTOPICALSOLUTIONANDA0765261b2f6145-b338-42ed-88a7-f4da65c59164

fluorouracil 50 mg/ml topical solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1435470258NDASolco Healthcare U.S., Llc2010-06-01FLUOROURACILTOPICALSOLUTIONNDA016831e4acd6ec-d981-4756-9c59-7ee981be9c12

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724063ANDATaro Pharmaceuticals U.S.A., Inc.2003-11-05FLUOROURACILTOPICALSOLUTIONANDA0765261b2f6145-b338-42ed-88a7-f4da65c59164

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drugin other drug docs
1ANDA076526FLUOROURACILTARO PHARMACEUTICALS USA INC2003-11-05ANDA076526_001, ANDA076526_002Fluorouracil Topical Cream
2ANDA077524FLUOROURACILSPEAR PHARMACEUTICALS INC2008-04-11ANDA077524_001Fluorouracil Topical Cream
3ANDA090368FLUOROURACILTARO PHARMACEUTICAL INDUSTRIES LTD2010-03-05ANDA090368_001Fluorouracil Topical Cream
4ANDA203122FLUOROURACILSPEAR PHARMACEUTICALS INC2015-04-20ANDA203122_001Fluorouracil Topical Cream
5NDA016765FLUOROPLEXTrueELORAC INCNDA016765_001Fluorouracil Topical Cream
6NDA016831EFUDEXVALEANT PHARMACEUTICALS INTERNATIONALNDA016831_001, NDA016831_002, NDA016831_003Fluorouracil Topical Cream
7NDA016988FLUOROPLEXAQUA PHARMACEUTICALS LLCNDA016988_001Fluorouracil Topical Cream
8NDA020985CARACVALEANT PHARMACEUTICALS NORTH AMERICA LLC2000-10-27p6670335, TREATMENT OF ACTINIC KERATOSIS, SUBSTANCENDA020985_001Fluorouracil Topical Cream
9NDA022259TOLAKHILL DERMACEUTICALS INC2015-09-18p7169401, SUBSTANCENEW PRODUCT [2018-09-18]NDA022259_001Fluorouracil Topical Cream

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076526_001RXFLUOROURACIL (2%)TOPICALSOLUTIONFalseAT2003-11-05FLUOROURACIL
2ANDA076526_002RXFLUOROURACIL (5%)TOPICALSOLUTIONFalseAT2003-11-05FLUOROURACIL
3ANDA077524_001RXFLUOROURACIL (5%)TOPICALCREAMFalseAB2008-04-11FLUOROURACIL
4ANDA090368_001RXFLUOROURACIL (5%)TOPICALCREAMFalseAB2010-03-05FLUOROURACIL
5ANDA203122_001RXFLUOROURACIL (0.5%)TOPICALCREAMFalseAB2015-04-20FLUOROURACIL
6NDA016765_001discontinuedFLUOROURACIL (1%)TOPICALSOLUTIONFalseFLUOROPLEX
7NDA016831_001RXFLUOROURACIL (2%)TOPICALSOLUTIONTrueATEFUDEX
8NDA016831_002RXFLUOROURACIL (5%)TOPICALSOLUTIONTrueATEFUDEX
9NDA016831_003RXFLUOROURACIL (5%)TOPICALCREAMTrueABEFUDEX
10NDA016988_001RXFLUOROURACIL (1%)TOPICALCREAMTrueFLUOROPLEX
11NDA020985_001RXFLUOROURACIL (0.5%)TOPICALCREAMTrueAB2000-10-27CARAC
12NDA022259_001RXFLUOROURACIL (4%)TOPICALCREAMTrue2015-09-18TOLAK

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6670335 (view patent)2021-06-02NDA020985Fluorouracil Topical Cream
2p7169401 (view patent)2023-07-18NDA022259Fluorouracil Topical Cream

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
11b2f6145-b338-42ed-88a7-f4da65c59164 (view SPL)FluorouracilTopical Solution USP, 2% and 5%prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2012-07-132516724062, 516724063
235de1c1c-bef5-46c5-b6f8-ea032147411c (view SPL)EFUDEX (fluorouracil) TOPICAL SOLUTIONS AND CREAMprescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2014-05-053001873202, 001873203, 001873204Fluorouracil Topical Cream
3e4acd6ec-d981-4756-9c59-7ee981be9c12 (view SPL)FLUOROURACIL TOPICAL SOLUTIONSprescriptionHuman PrescriptionSolco Healthcare U.S., LlcANALYSIS, API MANUFACTURE, LABEL2010-05-241435470258, 435470259

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