Orange Book product · Generic (ANDA)
SULFAMETHOXAZOLE AND TRIMETHOPRIM
SULFAMETHOXAZOLE; TRIMETHOPRIM
At a glance
Aug 30, 2017
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 30, 2017
8 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Strength
80MG/ML;16MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 206607
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of SULFAMETHOXAZOLE; TRIMETHOPRIM
- 1984SULFAMETHOXAZOLE AND TRIMETHOPRIMBrand (NDA)
NDA 018946 · HEATHER
- 1983SULFAMETHOXAZOLE AND TRIMETHOPRIMBrand (NDA)
NDA 018812 · TEVA
- 1983SULFATRIMBrand (NDA)
NDA 018615 · PHARM ASSOC
- 1982SULFAMETHOXAZOLE AND TRIMETHOPRIMBrand (NDA)
NDA 018598 · FOSUN PHARMA
- —BACTRIMBrand (NDA)
NDA 018374 · SUN PHARM INDS INC
- —SEPTRABrand (NDA)
NDA 018452 · MONARCH PHARMS
- —BACTRIMBrand (NDA)
NDA 017560 · SUN PHARM INDUSTRIES
- —SEPTRABrand (NDA)
NDA 017598 · MONARCH PHARMS
- —BACTRIMBrand (NDA)
NDA 017377 · SUN PHARM INDUSTRIES
- —SEPTRABrand (NDA)
NDA 017376 · MONARCH PHARMS
- —SULFAMETHOXAZOLE AND TRIMETHOPRIMBrand (NDA)
NDA 018242 · TEVA
- 2022SULFAMETHOXAZOLE AND TRIMETHOPRIMGeneric (ANDA)
ANDA 214330 · NOVITIUM PHARMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
