Sulfamethoxazole / Trimethoprim Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Parenteral Medicines, Inc (2015-11-05)
Oldest Current Product
1991-11-01
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\SULFAMETHOXAZOLE:TRIMETHOPRIM
FDAOB
INJECTION\INJECTION\SULFAMETHOXAZOLE: TRIMETHOPRIM\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\SULFAMETHOXAZOLE: TRIMETHOPRIM
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\SULFAMETHOXAZOLE: TRIMETHOPRIM

product(s) by strength(s)

sulfamethoxazole 80 mg/ml / trimethoprim 16 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007039503ANDATeva Parenteral Medicines, Inc1991-11-01SULFAMETHOXAZOLE, TRIMETHOPRIMINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA073303b89b5502-ce87-45a6-a43c-9891da3cfca4
2007039514ANDATeva Parenteral Medicines, Inc1991-11-01SULFAMETHOXAZOLE, TRIMETHOPRIMINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA073303b89b5502-ce87-45a6-a43c-9891da3cfca4
3007039526ANDATeva Parenteral Medicines, Inc1991-11-01SULFAMETHOXAZOLE, TRIMETHOPRIMINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA073303b89b5502-ce87-45a6-a43c-9891da3cfca4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070223SULFAMETHOXAZOLE AND TRIMETHOPRIMTrueABRAXIS PHARMACEUTICAL PRODUCTS1987-12-29ANDA070223_001
2ANDA070627SULFAMETHOXAZOLE AND TRIMETHOPRIMTrueHIKMA MAPLE LTD1987-12-29ANDA070627_001
3ANDA070628SULFAMETHOXAZOLE AND TRIMETHOPRIMTrueHIKMA MAPLE LTD1987-12-29ANDA070628_001
4ANDA071556SULFAMETHOXAZOLE AND TRIMETHOPRIMTrueWATSON LABORATORIES INC1987-12-29ANDA071556_001
5ANDA072383SULFAMETHOXAZOLE AND TRIMETHOPRIMTrueBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1992-04-29ANDA072383_001
6ANDA073199SULFAMETHOXAZOLE AND TRIMETHOPRIMTrueHOSPIRA INC1992-09-11ANDA073199_001
7ANDA073303SULFAMETHOXAZOLE AND TRIMETHOPRIMTEVA PHARMACEUTICALS USA1991-10-31ANDA073303_001
8NDA018374BACTRIMTrueMUTUAL PHARMACEUTICAL CO INCNDA018374_001
9NDA018452SEPTRATrueMONARCH PHARMACEUTICALS INCNDA018452_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA070223_001discontinuedSULFAMETHOXAZOLE (80MG/ML), TRIMETHOPRIM (16MG/ML)INJECTIONFalse1987-12-29SULFAMETHOXAZOLE AND TRIMETHOPRIM
2ANDA070627_001discontinuedTRIMETHOPRIM (16MG/ML), SULFAMETHOXAZOLE (80MG/ML)INJECTIONFalse1987-12-29SULFAMETHOXAZOLE AND TRIMETHOPRIM
3ANDA070628_001discontinuedSULFAMETHOXAZOLE (80MG/ML), TRIMETHOPRIM (16MG/ML)INJECTIONFalse1987-12-29SULFAMETHOXAZOLE AND TRIMETHOPRIM
4ANDA071556_001discontinuedSULFAMETHOXAZOLE (80MG/ML), TRIMETHOPRIM (16MG/ML)INJECTIONFalse1987-12-29SULFAMETHOXAZOLE AND TRIMETHOPRIM
5ANDA072383_001discontinuedTRIMETHOPRIM (16MG/ML), SULFAMETHOXAZOLE (80MG/ML)INJECTIONFalse1992-04-29SULFAMETHOXAZOLE AND TRIMETHOPRIM
6ANDA073199_001discontinuedSULFAMETHOXAZOLE (80MG/ML), TRIMETHOPRIM (16MG/ML)INJECTIONFalse1992-09-11SULFAMETHOXAZOLE AND TRIMETHOPRIM
7ANDA073303_001RXSULFAMETHOXAZOLE (80MG/ML), TRIMETHOPRIM (16MG/ML)INJECTIONTrue1991-10-31SULFAMETHOXAZOLE AND TRIMETHOPRIM
8NDA018374_001discontinuedSULFAMETHOXAZOLE (80MG/ML), TRIMETHOPRIM (16MG/ML)INJECTIONFalseBACTRIM
9NDA018452_001discontinuedSULFAMETHOXAZOLE (80MG/ML), TRIMETHOPRIM (16MG/ML)INJECTIONFalseSEPTRA

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1b89b5502-ce87-45a6-a43c-9891da3cfca4 (view SPL)Sulfamethoxazole and Trimethoprim Injection USPprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-11-059007039503, 007039514, 007039526

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