Orange Book product · Brand (NDA)
TRIMETHOPRIM
TRIMETHOPRIM
At a glance
Jul 30, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 30, 1982
44 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
TRIMETHOPRIM
Strength
100MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 018679
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —PROLOPRIMBrand (NDA)
NDA 017943 · MONARCH PHARMS
- —TRIMPEXBrand (NDA)
NDA 017952 · ROCHE
- 2022TRIMETHOPRIMGeneric (ANDA)
ANDA 216393 · NOVITIUM PHARMA
- 2011TRIMETHOPRIMGeneric (ANDA)
ANDA 091437 · NOVEL LABS INC
- 1987TRIMETHOPRIMGeneric (ANDA)
ANDA 071259 · TEVA
- 1986TRIMETHOPRIMGeneric (ANDA)
ANDA 070495 · SUN PHARM INDUSTRIES
- 1986TRIMETHOPRIMGeneric (ANDA)
ANDA 070494 · SUN PHARM INDUSTRIES
- 1985TRIMETHOPRIMGeneric (ANDA)
ANDA 070049 · WATSON LABS
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.
