Orange Book product · Brand (NDA)
ORUDIS
KETOPROFEN
At a glance
Jul 31, 1987
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 31, 1987
39 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOPROFEN
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 018754
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2009NEXCEDEBrand (NDA)
NDA 022470 · NOVARTIS
- 1995ACTRONBrand (NDA)
NDA 020499 · BAYER
- 1995ORUDIS KTBrand (NDA)
NDA 020429 · WYETH CONS
- 1995ORUVAILBrand (NDA)
NDA 019816 · WYETH PHARMS INC
- 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.
