Trimethoprim Oral Solution

Brand(s)
Primsol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Fsc Laboratories, Inc (2014-09-25)
Oldest Current Product
2000-01-24
License(s)
NDA
RxNORM
ORAL SOLUTION\TRIMETHOPRIM
FDAOB
ORAL\SOLUTION\TRIMETHOPRIM HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\TRIMETHOPRIM HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\TRIMETHOPRIM

product(s) by strength(s)

trimethoprim 10 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1135510501PrimsolNDAFsc Laboratories, Inc2000-01-24TRIMETHOPRIM HYDROCHLORIDEORALSOLUTIONNDA074973a06ea7d8-a884-4b62-a87f-c36d824f2aa4

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA074374PRIMSOLTrueFSC LABORATORIES INC1995-06-23ANDA074374_001
2NDA074973PRIMSOLFSC LABORATORIES INC2000-01-24p5962461
p5763449
NDA074973_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA074374_001discontinuedTRIMETHOPRIM HYDROCHLORIDE (EQ 25MG BASE/5ML)ORALSOLUTIONFalse1995-06-23PRIMSOL
2NDA074973_001RXTRIMETHOPRIM HYDROCHLORIDE (EQ 50MG BASE/5ML)ORALSOLUTIONTrue2000-01-24PRIMSOL

patent(s)

#idexpiration dateapplication(s)
1p5763449 (view patent)2016-08-07NDA074973
2p5962461 (view patent)2016-08-07NDA074973

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1a06ea7d8-a884-4b62-a87f-c36d824f2aa4 (view SPL)Primsol Solution(trimethoprim hydrochloride oral solution)Dye-free, alcohol-free, flavored solution,50 mg trimethoprim per 5 mLprescriptionHuman PrescriptionFsc Laboratories, Inc2014-09-253135510501

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