Orange Book product · Brand (NDA)
ACTRON
KETOPROFEN
At a glance
Oct 06, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 06, 1995
31 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOPROFEN
Strength
12.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020499
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.
- 2009NEXCEDEBrand (NDA)
NDA 022470 · NOVARTIS
- 1995ORUDIS KTBrand (NDA)
NDA 020429 · WYETH CONS
- 1995ORUVAILBrand (NDA)
NDA 019816 · WYETH PHARMS INC
- 1987ORUDISBrand (NDA)
NDA 018754 · WYETH AYERST
- 2002KETOPROFENGeneric (ANDA)
ANDA 075679 · MYLAN
- 2002KETOPROFENGeneric (ANDA)
ANDA 075364 · PERRIGO
- 1999KETOPROFENGeneric (ANDA)
ANDA 075270 · ACTAVIS LABS FL INC
- 1997KETOPROFENGeneric (ANDA)
ANDA 074879 · ALKERMES GAINESVILLE
- 1996KETOPROFENGeneric (ANDA)
ANDA 074035 · RISING
- 1995KETOPROFENGeneric (ANDA)
ANDA 074024 · RISING
- 1993KETOPROFENGeneric (ANDA)
ANDA 074014 · MISEMER
- 1992KETOPROFENGeneric (ANDA)
ANDA 073515 · TEVA
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.
