Sulfamethoxazole / Trimethoprim Oral Suspension

Brand(s)
Sulfatrim
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hi-Tech Pharmacal Co., Inc. (2013-06-12)
Oldest Current Product
1983-07-01
License(s)
NDA, ANDA
RxNORM
ORAL SUSPENSION\SULFAMETHOXAZOLE:TRIMETHOPRIM
FDAOB
ORAL\SUSPENSION\SULFAMETHOXAZOLE: TRIMETHOPRIM
SPL Active
ORAL\SUSPENSION\SULFAMETHOXAZOLE: TRIMETHOPRIM
SPL Moiety
ORAL\SUSPENSION\SULFAMETHOXAZOLE: TRIMETHOPRIM

product(s) by strength(s)

sulfamethoxazole 40 mg/ml / trimethoprim 8 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1548790007SulfatrimNDASti Pharma1983-07-01SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSIONNDA0186153ef596c8-689e-4349-a5dc-11645f8332ef

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006031684ANDAQualitest Pharmaceuticals2007-01-24SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSIONANDA077785c12366c1-2e7f-426d-b5ca-bba7b460fbe8
2006031685ANDAQualitest Pharmaceuticals2007-01-24SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSIONANDA077785c12366c1-2e7f-426d-b5ca-bba7b460fbe8
3503830823ANDAHi-Tech Pharmacal Co., Inc.1997-12-29SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSIONANDA07465006e3d76b-8f16-4d53-bb9f-201cb6a72fb8
4503830824ANDAHi-Tech Pharmacal Co., Inc.1997-12-29SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSIONANDA07465006e3d76b-8f16-4d53-bb9f-201cb6a72fb8
5658620496ANDAAurobindo Pharma Limited2010-06-08SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSIONANDA091348a6182855-6287-45e9-b6b4-7b57efc9c76e

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001214793ANDAPharmaceutical Associates, Inc.2008-07-02SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSION000935476ANDA077612afb1693a-63d4-4356-976a-51a2d8dcde68

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340779ANDAApotheca, Inc2009-11-03SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSION503830823ANDA074650fea44910-400c-4688-bedc-bbb1615cd8f5
2178560823ANDAAtlantic Biologicals Corps1997-12-29SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSION503830823ANDA074650c9676c8a-4597-4dcf-8944-18ecc96004e2
3216950701ANDARebel Distributors Corp1997-12-29SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSION503830823ANDA0746503e568a2e-421d-4456-a8bf-d983ecee7ad6
4529590766ANDAH.J. Harkins Company, Inc.1997-12-29SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSION503830823ANDA074650c8833d0d-9e8e-40cf-b6df-d559ea83b7b2
5548680276ANDAPhysicians Total Care, Inc.1997-12-29SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSION503830823ANDA07465007b8b958-4855-47d8-9cc6-681a0131ce77
6687889102ANDAPreferred Pharmaceuticals, Inc.2004-08-06SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSION503830823ANDA074650a2978977-8ae3-438e-9059-ea8bda49741d
7687889512ANDAPreferred Pharmaceuticals, Inc.2014-02-12SULFAMETHOXAZOLE, TRIMETHOPRIMORALSUSPENSION658620496ANDA091348bbad2036-e2a8-4c56-bb92-dea833598ebc

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070028SULFAMETHOXAZOLE AND TRIMETHOPRIMTrueANI PHARMACEUTICALS INC1987-06-02ANDA070028_001
2ANDA070063SULMEPRIMTrueUSL PHARMA INC1986-08-01ANDA070063_001
3ANDA070064SULMEPRIM PEDIATRICTrueUSL PHARMA INC1986-08-01ANDA070064_001
4ANDA072289TRIMETH/SULFATrueALPHARMA US PHARMACEUTICALS DIVISION1988-05-23ANDA072289_001
5ANDA072398TRIMETH/SULFATrueALPHARMA US PHARMACEUTICALS DIVISION1988-05-23ANDA072398_001
6ANDA072399TRIMETH/SULFATrueNASKA PHARMACAL CO INC DIV RUGBY DARBY GROUP COSMETICS1988-05-23ANDA072399_001
7ANDA074650SULFAMETHOXAZOLE AND TRIMETHOPRIMHI TECH PHARMACAL CO INC1997-12-29ANDA074650_001
8ANDA077612SULFAMETHOXAZOLE AND TRIMETHOPRIMTrueTEVA PHARMACEUTICALS USA2006-11-13ANDA077612_001
9ANDA077785SULFAMETHOXAZOLE AND TRIMETHOPRIMVINTAGE PHARMACEUTICALS LLC2007-01-24ANDA077785_001
10ANDA091348SULFAMETHOXAZOLE AND TRIMETHOPRIMAUROBINDO PHARMA LTD2010-06-08ANDA091348_001
11NDA017560BACTRIMTrueMUTUAL PHARMACEUTICAL CO INCNDA017560_001, NDA017560_002
12NDA017598SEPTRATrueMONARCH PHARMACEUTICALS INCNDA017598_001, NDA017598_002
13NDA018615SULFATRIMSTI PHARMA LLC1983-01-07NDA018615_001, NDA018615_002
14NDA018812SULFAMETHOXAZOLE AND TRIMETHOPRIMTrueTEVA PHARMACEUTICALS USA INC1983-01-28NDA018812_001, NDA018812_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070028_001discontinuedTRIMETHOPRIM (40MG/5ML), SULFAMETHOXAZOLE (200MG/5ML)ORALSUSPENSIONFalse1987-06-02SULFAMETHOXAZOLE AND TRIMETHOPRIM
2ANDA070063_001discontinuedSULFAMETHOXAZOLE (200MG/5ML), TRIMETHOPRIM (40MG/5ML)ORALSUSPENSIONFalse1986-08-01SULMEPRIM
3ANDA070064_001discontinuedTRIMETHOPRIM (40MG/5ML), SULFAMETHOXAZOLE (200MG/5ML)ORALSUSPENSIONFalse1986-08-01SULMEPRIM PEDIATRIC
4ANDA072289_001discontinuedTRIMETHOPRIM (40MG/5ML), SULFAMETHOXAZOLE (200MG/5ML)ORALSUSPENSIONFalse1988-05-23TRIMETH/SULFA
5ANDA072398_001discontinuedSULFAMETHOXAZOLE (200MG/5ML), TRIMETHOPRIM (40MG/5ML)ORALSUSPENSIONFalse1988-05-23TRIMETH/SULFA
6ANDA072399_001discontinuedTRIMETHOPRIM (40MG/5ML), SULFAMETHOXAZOLE (200MG/5ML)ORALSUSPENSIONFalse1988-05-23TRIMETH/SULFA
7ANDA074650_001RXSULFAMETHOXAZOLE (200MG/5ML), TRIMETHOPRIM (40MG/5ML)ORALSUSPENSIONTrueAB1997-12-29SULFAMETHOXAZOLE AND TRIMETHOPRIM
8ANDA077612_001discontinuedTRIMETHOPRIM (40MG/5ML), SULFAMETHOXAZOLE (200MG/5ML)ORALSUSPENSIONFalse2006-11-13SULFAMETHOXAZOLE AND TRIMETHOPRIM
9ANDA077785_001RXSULFAMETHOXAZOLE (200MG/5ML), TRIMETHOPRIM (40MG/5ML)ORALSUSPENSIONFalseAB2007-01-24SULFAMETHOXAZOLE AND TRIMETHOPRIM
10ANDA091348_001RXTRIMETHOPRIM (40MG/5ML), SULFAMETHOXAZOLE (200MG/5ML)ORALSUSPENSIONFalseAB2010-06-08SULFAMETHOXAZOLE AND TRIMETHOPRIM
11NDA017560_001discontinuedTRIMETHOPRIM (40MG/5ML), SULFAMETHOXAZOLE (200MG/5ML)ORALSUSPENSIONFalseBACTRIM
12NDA017560_002discontinuedSULFAMETHOXAZOLE (200MG/5ML), TRIMETHOPRIM (40MG/5ML)ORALSUSPENSIONFalseBACTRIM
13NDA017598_001discontinuedSULFAMETHOXAZOLE (200MG/5ML), TRIMETHOPRIM (40MG/5ML)ORALSUSPENSIONFalseSEPTRA
14NDA017598_002discontinuedSULFAMETHOXAZOLE (200MG/5ML), TRIMETHOPRIM (40MG/5ML)ORALSUSPENSIONFalse1986-02-12SEPTRA
15NDA018615_001RXSULFAMETHOXAZOLE (200MG/5ML), TRIMETHOPRIM (40MG/5ML)ORALSUSPENSIONFalseAB1983-01-07SULFATRIM
16NDA018615_002discontinuedTRIMETHOPRIM (40MG/5ML), SULFAMETHOXAZOLE (200MG/5ML)ORALSUSPENSIONFalse1983-01-07SULFATRIM
17NDA018812_001discontinuedSULFAMETHOXAZOLE (200MG/5ML), TRIMETHOPRIM (40MG/5ML)ORALSUSPENSIONFalse1983-01-28SULFAMETHOXAZOLE AND TRIMETHOPRIM
18NDA018812_002discontinuedTRIMETHOPRIM (40MG/5ML), SULFAMETHOXAZOLE (200MG/5ML)ORALSUSPENSIONFalse1983-06-10SULFAMETHOXAZOLE AND TRIMETHOPRIM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
106e3d76b-8f16-4d53-bb9f-201cb6a72fb8 (view SPL)Sulfamethoxazole and Trimethoprim Oral Suspension, USPprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.MANUFACTURE2013-06-129503830823, 503830824
207b8b958-4855-47d8-9cc6-681a0131ce77 (view SPL)Sulfamethoxazole and Trimethoprim Oral Suspension, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-05-081548680276
33e568a2e-421d-4456-a8bf-d983ecee7ad6 (view SPL)Sulfamethoxazole and Trimethoprim Oral Suspension, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-011216950701
43ef596c8-689e-4349-a5dc-11645f8332ef (view SPL)SULFATRIMTM (Sulfamethoxazole and Trimethoprim Oral Suspension, USP)prescriptionHuman PrescriptionSti Pharma2013-11-123548790007
5a2978977-8ae3-438e-9059-ea8bda49741d (view SPL)Sulfamethoxazole and Trimethoprim Oral Suspension, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-02-142687889102
6a6182855-6287-45e9-b6b4-7b57efc9c76e (view SPL)Sulfamethoxazole and Trimethoprim Oral Suspension, USPRx onlyprescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, MANUFACTURE2013-09-056658620496
7afb1693a-63d4-4356-976a-51a2d8dcde68 (view SPL)SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION USPprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE, REPACK2009-12-201001214793
8bbad2036-e2a8-4c56-bb92-dea833598ebc (view SPL)Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2014-02-191687889512
9c12366c1-2e7f-426d-b5ca-bba7b460fbe8 (view SPL)SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP (CHERRY FLAVOR) and SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP (GRAPE FLAVOR) 200 mg/40 mg per 5 mLprescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-07-165006031684, 006031685
10c8833d0d-9e8e-40cf-b6df-d559ea83b7b2 (view SPL)Sulfamethoxazole and Trimethoprim Oral Suspension, USPprescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-10-261529590766
11c9676c8a-4597-4dcf-8944-18ecc96004e2 (view SPL)Sulfamethoxazole and Trimethoprim Oral Suspension, USPprescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2011-10-133178560823
12fea44910-400c-4688-bedc-bbb1615cd8f5 (view SPL)SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 200MG/40MG PER 5ML CHERRY Rx OnlyprescriptionHuman PrescriptionApotheca, Inc2010-04-221126340779

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