Orange Book product · Brand (NDA)
SEPTRA
SULFAMETHOXAZOLE; TRIMETHOPRIM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Strength
200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 017598
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 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
- —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
- 2021SULFAMETHOXAZOLE AND TRIMETHOPRIMGeneric (ANDA)
ANDA 212699 · LUPIN
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.
