Trimethoprim Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2013-10-10)
Oldest Current Product
1990-09-30
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\TRIMETHOPRIM
FDAOB
ORAL\TABLET\TRIMETHOPRIM
SPL Active
ORAL\TABLET\TRIMETHOPRIM
SPL Moiety
ORAL\TABLET\TRIMETHOPRIM

product(s) by strength(s)

trimethoprim 100 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000932158NDATeva Pharmaceuticals Usa Inc1990-09-30TRIMETHOPRIMORALTABLETNDA01867924daed1d-d20b-4b39-bfa3-efaf05c00380

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005915571ANDAWatson Laboratories, Inc.2010-04-04TRIMETHOPRIMORALTABLETANDA070049a50529de-7b7d-4ac4-bc51-553a329a5fb0
2400320330ANDANovel Laboratories, Inc.2014-03-04TRIMETHOPRIMORALTABLETANDA091437b27e43b5-670b-43f6-b28b-413e54f914da
3433860330ANDAGavis Pharmaceuticals, Llc2011-06-24TRIMETHOPRIMORALTABLETANDA091437249e938d-f181-47c4-a082-372d65462f33

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910845ANDAAvkare, Inc.2013-05-06TRIMETHOPRIMORALTABLET433860330ANDA0914372b46be6f-424b-7a7e-ef82-94f910a8439a
2502680775ANDAAvpak2013-07-31TRIMETHOPRIMORALTABLET005915571ANDA07004915dcd160-eab4-b2a5-c97e-8bd4ad2953bb
3521250701ANDARemedyrepack Inc.2013-09-24TRIMETHOPRIMORALTABLET433860330ANDA091437e6b1e2ee-989a-4f29-8c82-634a64e0d67c
4548681616ANDAPhysicians Total Care, Inc.2012-05-02TRIMETHOPRIMORALTABLET005915571ANDA0700497d25e3f9-7b0d-452d-953e-f100bb0f2db7
5681512010ANDACarilion Materials Management2010-04-04TRIMETHOPRIMORALTABLET005915571ANDA070049e38742cd-3411-46bf-a74b-526b16c79729

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070049TRIMETHOPRIMWATSON LABORATORIES INC1985-06-06ANDA070049_001
2ANDA070494TRIMETHOPRIMTrueMUTUAL PHARMACEUTICAL CO INC1986-01-22ANDA070494_001
3ANDA070495TRIMETHOPRIMTrueMUTUAL PHARMACEUTICAL CO INC1986-09-24ANDA070495_001
4ANDA071259TRIMETHOPRIMTrueTEVA PHARMACEUTICALS USA INC1987-06-18ANDA071259_001
5ANDA091437TRIMETHOPRIMNOVEL LABORATORIES INC2011-06-15ANDA091437_001
6NDA017943PROLOPRIMTrueMONARCH PHARMACEUTICALS INCNDA017943_001, NDA017943_003
7NDA017952TRIMPEXTrueHOFFMANN LA ROCHE INCNDA017952_001, NDA017952_002
8NDA018679TRIMETHOPRIMTEVA PHARMACEUTICALS USA INC1982-07-30NDA018679_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070049_001RXTRIMETHOPRIM (100MG)ORALTABLETFalseAB1985-06-06TRIMETHOPRIM
2ANDA070494_001discontinuedTRIMETHOPRIM (100MG)ORALTABLETFalse1986-01-22TRIMETHOPRIM
3ANDA070495_001discontinuedTRIMETHOPRIM (200MG)ORALTABLETFalse1986-09-24TRIMETHOPRIM
4ANDA071259_001discontinuedTRIMETHOPRIM (200MG)ORALTABLETFalse1987-06-18TRIMETHOPRIM
5ANDA091437_001RXTRIMETHOPRIM (100MG)ORALTABLETFalseAB2011-06-15TRIMETHOPRIM
6NDA017943_001discontinuedTRIMETHOPRIM (100MG)ORALTABLETFalsePROLOPRIM
7NDA017943_003discontinuedTRIMETHOPRIM (200MG)ORALTABLETFalse1982-07-14PROLOPRIM
8NDA017952_001discontinuedTRIMETHOPRIM (100MG)ORALTABLETFalseTRIMPEX
9NDA017952_002discontinuedTRIMETHOPRIM (200MG)ORALTABLETFalse1982-11-09TRIMPEX
10NDA018679_001RXTRIMETHOPRIM (100MG)ORALTABLETTrueAB1982-07-30TRIMETHOPRIM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
115dcd160-eab4-b2a5-c97e-8bd4ad2953bb (view SPL)TrimethoprimTablets USPRx onlyprescriptionHuman PrescriptionAvpak2014-10-222502680775
2249e938d-f181-47c4-a082-372d65462f33 (view SPL)Trimethoprim Tablets, USPprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcMANUFACTURE2011-06-141433860330
324daed1d-d20b-4b39-bfa3-efaf05c00380 (view SPL)TRIMETHOPRIM TABLETS, USP21582159Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2013-10-108000932158
42b46be6f-424b-7a7e-ef82-94f910a8439a (view SPL)Trimethoprim Tablets, USPprescriptionHuman PrescriptionAvkare, Inc.2013-05-061422910845
57d25e3f9-7b0d-452d-953e-f100bb0f2db7 (view SPL)TrimethoprimTablets USPRevised: June 2006Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-05-252548681616
6a50529de-7b7d-4ac4-bc51-553a329a5fb0 (view SPL)TrimethoprimTablets USPRevised: June 2006Rx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-11-042005915571
7b27e43b5-670b-43f6-b28b-413e54f914da (view SPL)Trimethoprim Tablets, USPprescriptionHuman PrescriptionNovel Laboratories, Inc.MANUFACTURE2014-03-042400320330
8e38742cd-3411-46bf-a74b-526b16c79729 (view SPL)Trimethoprim Tablets USP Revised: June 2006 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-11-042681512010
9e6b1e2ee-989a-4f29-8c82-634a64e0d67c (view SPL)Trimethoprim Tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-09-241521250701

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