Orange Book product · Brand (NDA)
ORUVAIL
KETOPROFEN
At a glance
Feb 08, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 08, 1995
31 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOPROFEN
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 019816
Product number
003
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
- 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.
