Fluorouracil Injectable Solution

Brand(s)
Adrucil
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Accord Healthcare Inc. (2014-03-01)
Oldest Current Product
2000-07-12
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\FLUOROURACIL
FDAOB
INJECTION\INJECTION\FLUOROURACIL\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\FLUOROURACIL
INTRAVENOUS\INJECTION\FLUOROURACIL
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\FLUOROURACIL
INTRAVENOUS\INJECTION\FLUOROURACIL

product(s) by strength(s)

fluorouracil 50 mg/ml injectable solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690173ANDAPfizer Labs2012-07-18FLUOROURACILINTRAVENOUSINJECTION, SOLUTIONANDA202668e301c810-0edc-4d21-8ccd-ec9653249019
2000690176ANDAPfizer Labs2012-07-18FLUOROURACILINTRAVENOUSINJECTION, SOLUTIONANDA20266964b6cb19-b6c0-4e02-9fae-39d5d61e15e4
3007033015AdrucilANDATeva Parenteral Medicines, Inc2003-10-01FLUOROURACILINTRAVENOUSINJECTIONANDA040333e0794add-67a7-4308-93e9-f889472716cc
4007033018AdrucilANDATeva Parenteral Medicines, Inc2003-10-01FLUOROURACILINTRAVENOUSINJECTIONANDA040334b90e0da7-f702-4f09-9488-74f2bb20e9ac
5007033019AdrucilANDATeva Parenteral Medicines, Inc2003-10-01FLUOROURACILINTRAVENOUSINJECTIONANDA040334b90e0da7-f702-4f09-9488-74f2bb20e9ac
6167290276ANDAAccord Healthcare Inc.2014-02-01FLUOROURACILINTRAVENOUSINJECTION, SOLUTIONANDA040743, ANDA04079866d451fe-2436-494c-80c5-4528c8e34369, 8eff167f-203a-4a81-b2fc-d8773bc3555e
7633230117ANDAApp Pharmaceuticals, Llc2000-07-12FLUOROURACILINTRAVENOUSINJECTION, SOLUTIONANDA040278, ANDA04027921af1777-87f7-4e40-9917-f1677e7ff1a5, a85ab26a-05ea-498f-8f34-564a925fa9d9, b4328ae3-f48f-40b1-9719-1c1aced7c734, beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff, c45f5286-a52b-43e5-8a6f-d0312e7da0c8, fdf2a165-2ca4-48be-89c1-570e6010b47c
8667580054ANDASandoz Inc2011-05-02FLUOROURACILINTRAVENOUSINJECTION, SOLUTIONANDA0912991b835751-d6a4-49b6-b0f8-23ab31b0d04e
9680010266ANDABluepoint Laboratories2014-12-15, 2014-12-16FLUOROURACILINTRAVENOUSINJECTION, SOLUTIONANDA040743, ANDA040798513ca7e7-6867-4f15-b688-6469bb8c82de, d91670fd-7825-4fb9-afc7-a03a595fc70c

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1667580044ANDASandoz Inc2008-09-10FLUOROURACILINTRAVENOUSINJECTION, SOLUTIONANDA0407721911e06a-2f16-4b99-adfa-4b914d559e1e

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040023ADRUCILTrueTEVA PARENTERAL MEDICINES INC1991-10-18ANDA040023_001
2ANDA040278FLUOROURACILFRESENIUS KABI USA LLC1998-09-30ANDA040278_001, ANDA040278_002
3ANDA040279FLUOROURACILFRESENIUS KABI USA LLC1998-09-30ANDA040279_001, ANDA040279_002
4ANDA040291FLUOROURACILTrueFRESENIUS KABI USA LLC1999-03-24ANDA040291_001
5ANDA040333FLUOROURACILTEVA PHARMACEUTICALS USA2000-01-27ANDA040333_001
6ANDA040334FLUOROURACILTEVA PHARMACEUTICALS USA2000-02-25ANDA040334_001, ANDA040334_002
7ANDA040379FLUOROURACILTrueFRESENIUS KABI USA LLC2000-11-15ANDA040379_001
8ANDA040743FLUOROURACILACCORD HEALTHCARE INC2007-04-26ANDA040743_001, ANDA040743_002
9ANDA040772FLUOROURACILTrueEBEWE PHARMA GES MBH NFG KG2008-08-11ANDA040772_001
10ANDA040798FLUOROURACILACCORD HEALTHCARE INC2007-04-26ANDA040798_001, ANDA040798_002
11ANDA081222ADRUCILTruePHARMACIA AND UPJOHN CO1991-06-28ANDA081222_001
12ANDA081225ADRUCILTrueTEVA PARENTERAL MEDICINES INC1991-08-28ANDA081225_001
13ANDA087791FLUOROURACILTrueMARCHAR LABORATORIES INC LTD1983-01-18ANDA087791_001
14ANDA087792FLUOROURACILTrueSPECTRUM PHARMACEUTICALS INC1982-10-13ANDA087792_001
15ANDA088766FLUOROURACILTrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1984-12-28ANDA088766_001
16ANDA088767FLUOROURACILTrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1984-12-28ANDA088767_001
17ANDA088929FLUOROURACILTrueABIC LTD1986-03-04ANDA088929_001
18ANDA089152FLUOROURACILTrueABRAXIS PHARMACEUTICAL PRODUCTS1986-03-21ANDA089152_001
19ANDA089428FLUOROURACILTrueABRAXIS PHARMACEUTICAL PRODUCTS1987-01-12ANDA089428_001
20ANDA089434FLUOROURACILTrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1987-03-26ANDA089434_001
21ANDA089508FLUOROURACILTrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1988-01-26ANDA089508_001
22ANDA089519FLUOROURACILTrueABRAXIS PHARMACEUTICAL PRODUCTS1987-03-12ANDA089519_001
23ANDA091299FLUOROURACILSANDOZ INC2011-05-02ANDA091299_001, ANDA091299_002
24ANDA202668FLUOROURACILMYLAN LABORATORIES LTD2012-07-17ANDA202668_001, ANDA202668_002
25ANDA202669FLUOROURACILMYLAN LABORATORIES LTD2012-07-17ANDA202669_001, ANDA202669_002
26NDA012209FLUOROURACILTrueVALEANT PHARMACEUTICALS INTERNATIONALNDA012209_001
27NDA017959ADRUCILTruePHARMACIA AND UPJOHN CONDA017959_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040023_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1991-10-18ADRUCIL
2ANDA040278_001RXFLUOROURACIL (2.5GM/50ML)INJECTIONTrueAP1998-09-30FLUOROURACIL
3ANDA040278_002RXFLUOROURACIL (5GM/100ML)INJECTIONTrueAP1998-09-30FLUOROURACIL
4ANDA040279_001RXFLUOROURACIL (1GM/20ML)INJECTIONTrueAP1998-09-30FLUOROURACIL
5ANDA040279_002RXFLUOROURACIL (500MG/10ML)INJECTIONTrueAP1998-09-30FLUOROURACIL
6ANDA040291_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1999-03-24FLUOROURACIL
7ANDA040333_001RXFLUOROURACIL (500MG/10ML)INJECTIONTrueAP2000-01-27FLUOROURACIL
8ANDA040334_001RXFLUOROURACIL (2.5GM/50ML)INJECTIONTrueAP2000-02-25FLUOROURACIL
9ANDA040334_002RXFLUOROURACIL (5GM/100ML)INJECTIONTrueAP2000-02-25FLUOROURACIL
10ANDA040379_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse2000-11-15FLUOROURACIL
11ANDA040743_001RXFLUOROURACIL (1GM/20ML)INJECTIONTrueAP2007-04-26FLUOROURACIL
12ANDA040743_002RXFLUOROURACIL (500MG/10ML)INJECTIONTrueAP2007-04-26FLUOROURACIL
13ANDA040772_001discontinuedFLUOROURACIL (500MG/10ML)INJECTIONFalse2008-08-11FLUOROURACIL
14ANDA040798_001RXFLUOROURACIL (5GM/100ML)INJECTIONTrueAP2007-04-26FLUOROURACIL
15ANDA040798_002RXFLUOROURACIL (2.5GM/50ML)INJECTIONTrueAP2007-04-26FLUOROURACIL
16ANDA081222_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1991-06-28ADRUCIL
17ANDA081225_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1991-08-28ADRUCIL
18ANDA087791_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1983-01-18FLUOROURACIL
19ANDA087792_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1982-10-13FLUOROURACIL
20ANDA088766_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1984-12-28FLUOROURACIL
21ANDA088767_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1984-12-28FLUOROURACIL
22ANDA088929_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1986-03-04FLUOROURACIL
23ANDA089152_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1986-03-21FLUOROURACIL
24ANDA089428_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1987-01-12FLUOROURACIL
25ANDA089434_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1987-03-26FLUOROURACIL
26ANDA089508_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1988-01-26FLUOROURACIL
27ANDA089519_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalse1987-03-12FLUOROURACIL
28ANDA091299_001RXFLUOROURACIL (2.5GM/50ML)INJECTIONFalseAP2011-05-02FLUOROURACIL
29ANDA091299_002RXFLUOROURACIL (5GM/100ML)INJECTIONFalseAP2011-05-02FLUOROURACIL
30ANDA202668_001RXFLUOROURACIL (500MG/10ML)INJECTIONFalseAP2012-07-17FLUOROURACIL
31ANDA202668_002RXFLUOROURACIL (1GM/20ML)INJECTIONFalseAP2012-07-17FLUOROURACIL
32ANDA202669_001RXFLUOROURACIL (2.5GM/50ML)INJECTIONFalseAP2012-07-17FLUOROURACIL
33ANDA202669_002RXFLUOROURACIL (5GM/100ML)INJECTIONFalseAP2012-07-17FLUOROURACIL
34NDA012209_001discontinuedFLUOROURACIL (500MG/10ML)INJECTIONFalseFLUOROURACIL
35NDA017959_001discontinuedFLUOROURACIL (50MG/ML)INJECTIONFalseADRUCIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11911e06a-2f16-4b99-adfa-4b914d559e1e (view SPL)Fluorouracil Injection, USPprescriptionHuman PrescriptionSandoz Inc2010-05-2511667580044
21b835751-d6a4-49b6-b0f8-23ab31b0d04e (view SPL)Fluorouracil Injection, USPprescriptionHuman PrescriptionSandoz Inc2011-04-061667580054
321af1777-87f7-4e40-9917-f1677e7ff1a5 (view SPL)Fluorouracil Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-07-232633230117
4513ca7e7-6867-4f15-b688-6469bb8c82de (view SPL)Rx Only Fluorouracil Injection, USP 500 mg/10 mL and 1 g/20 mLprescriptionHuman PrescriptionBluepoint LaboratoriesANALYSIS, MANUFACTURE2015-06-083680010266
564b6cb19-b6c0-4e02-9fae-39d5d61e15e4 (view SPL)Fluorouracil Injection, USPprescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2012-10-101000690176
666d451fe-2436-494c-80c5-4528c8e34369 (view SPL)Rx OnlyFluorouracil Injection, USP500 mg/10 mL and 1 g/20 mLprescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2014-03-012167290276
78eff167f-203a-4a81-b2fc-d8773bc3555e (view SPL)Rx OnlyFluorouracil Injection, USP2.5 gram/50 mL and 5 gram/100 mLprescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2014-03-012167290276
8a85ab26a-05ea-498f-8f34-564a925fa9d9 (view SPL)Fluorouracil Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-08-011633230117
9b4328ae3-f48f-40b1-9719-1c1aced7c734 (view SPL)Fluorouracil Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-05-141633230117
10b90e0da7-f702-4f09-9488-74f2bb20e9ac (view SPL)ADRUCIL (fluorouracil injection, USP)prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2012-08-142007033018, 007033019
11beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff (view SPL)Fluorouracil Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-09-302633230117
12c45f5286-a52b-43e5-8a6f-d0312e7da0c8 (view SPL)Fluorouracil Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-09-302633230117
13d91670fd-7825-4fb9-afc7-a03a595fc70c (view SPL)Rx Only Fluorouracil Injection, USP 2.5 gram/50 mL and 5 gram/100 mLprescriptionHuman PrescriptionBluepoint LaboratoriesANALYSIS, MANUFACTURE2015-06-083680010266
14e0794add-67a7-4308-93e9-f889472716cc (view SPL)ADRUCIL (fluorouracil injection,USP)prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2012-08-142007033015
15e301c810-0edc-4d21-8ccd-ec9653249019 (view SPL)Fluorouracil Injection, USPprescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2012-10-041000690173
16fdf2a165-2ca4-48be-89c1-570e6010b47c (view SPL)Fluorouracil Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2014-05-211633230117

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