Orange Book product · Brand (NDA)
SULFAMETHOXAZOLE AND TRIMETHOPRIM
SULFAMETHOXAZOLE; TRIMETHOPRIM
At a glance
May 19, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 19, 1982
44 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Strength
400MG;80MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018598
Product number
003
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
- —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
- 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.
