Furosemide Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2012-04-05)
Oldest Current Product
1987-04-22
License(s)
ANDA
RxNORM
ORAL SOLUTION\FUROSEMIDE
FDAOB
ORAL\SOLUTION\FUROSEMIDE
SPL Active
ORAL\SOLUTION\FUROSEMIDE
SPL Moiety
ORAL\SOLUTION\FUROSEMIDE

product(s) by strength(s)

furosemide 10 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543294ANDARoxane Laboratories, Inc1988-07-12FUROSEMIDEORALSOLUTIONANDA0704349e493331-dddd-496e-abf8-61747fb67aba
2604320613ANDAMorton Grove Pharmaceuticals, Inc.1987-10-02FUROSEMIDEORALSOLUTIONANDA07065530cd95a8-ee0d-413d-b26a-6f042e8e1892

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1680940756ANDAPrecision Dose Inc.2012-10-23FUROSEMIDEORALSOLUTION000543294ANDA0704344a746634-379b-4847-a965-7607d2a71bed

furosemide 8 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543298ANDARoxane Laboratories, Inc1987-04-22FUROSEMIDEORALSOLUTIONANDA0704339e493331-dddd-496e-abf8-61747fb67aba
2000548298ANDARoxane Laboratories, Inc1987-04-22FUROSEMIDEORALSOLUTIONANDA0704339e493331-dddd-496e-abf8-61747fb67aba

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551544915ANDACardinal Health1987-04-22FUROSEMIDEORALSOLUTION000548298ANDA070433230cb29d-697e-4257-aa33-683c8f26243f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070433FUROSEMIDEROXANE LABORATORIES INC1987-04-22ANDA070433_001
2ANDA070434FUROSEMIDEROXANE LABORATORIES INC1987-04-22ANDA070434_001
3ANDA070655FUROSEMIDEWOCKHARDT EU OPERATIONS (SWISS) AG1987-10-02ANDA070655_001
4NDA017688LASIXTrueSANOFI AVENTIS US LLCNDA017688_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070433_001RXFUROSEMIDE (40MG/5ML)ORALSOLUTIONFalse1987-04-22FUROSEMIDE
2ANDA070434_001RXFUROSEMIDE (10MG/ML)ORALSOLUTIONTrueAA1987-04-22FUROSEMIDE
3ANDA070655_001RXFUROSEMIDE (10MG/ML)ORALSOLUTIONFalseAA1987-10-02FUROSEMIDE
4NDA017688_001discontinuedFUROSEMIDE (10MG/ML)ORALSOLUTIONFalseLASIX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1230cb29d-697e-4257-aa33-683c8f26243f (view SPL)FUROSEMIDE Tablets USP, 20 mg, 40 mg, 80 mgFUROSEMIDE Oral Solution USP, 40 mg per 5 mL and 10 mg per mLprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-223551544915, 551544906, 551544908, 551544909Furosemide Oral Tablet
230cd95a8-ee0d-413d-b26a-6f042e8e1892 (view SPL)FUROSEMIDEORAL SOLUTION USP,10 mg/mLprescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2015-07-307604320613
34a746634-379b-4847-a965-7607d2a71bed (view SPL)FUROSEMIDE Oral Solution USP 40 mg per 4 mLprescriptionHuman PrescriptionPrecision Dose Inc.2013-01-181680940756
49e493331-dddd-496e-abf8-61747fb67aba (view SPL)FUROSEMIDE Tablets USP, 20 mg, 40 mg, 80 mgFUROSEMIDE Oral Solution USP, 40 mg per 5 mL and 10 mg per mLprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-04-057000543294, 000543298, 000548298, 000544297, 000544299, 000544301, 000548297, 000548299, 000548301Furosemide Oral Tablet

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