Orange Book product · Generic (ANDA)
KETOPROFEN
KETOPROFEN
At a glance
Feb 07, 2002
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 07, 2002
24 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOPROFEN
Strength
12.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 075364
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of KETOPROFEN
- 2009NEXCEDEBrand (NDA)
NDA 022470 · NOVARTIS
- 1995ACTRONBrand (NDA)
NDA 020499 · BAYER
- 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
- 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.
