Orange Book product · Brand (NDA)
ORUDIS
KETOPROFEN
At a glance
Jan 09, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 09, 1986
41 yr ago
Today
Pharmaceutical detail
Active ingredient
KETOPROFEN
Strength
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
002
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.
