Orange Book product · Generic (ANDA)
KETOTIFEN FUMARATE
KETOTIFEN FUMARATE
At a glance
May 09, 2006
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 09, 2006
20 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOTIFEN FUMARATE
Strength
EQ 0.025% BASE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
ANDA 077354
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of KETOTIFEN FUMARATE
- 2022ACUVUE THERAVISION WITH KETOTIFENBrand (NDA)
NDA 022388 · JOHNSON JOHNSON VISN
- 2006ALAWAYBrand (NDA)
NDA 021996 · BAUSCH AND LOMB
- 2006ZADITORBrand (NDA)
NDA 021066 · ALCON PHARMA
- 2020ALAWAYGeneric (ANDA)
ANDA 208158 · BAUSCH AND LOMB INC
- 2020KETOTIFEN FUMARATEGeneric (ANDA)
ANDA 204059 · UNICHEM
- 2008ZADITORGeneric (ANDA)
ANDA 077200 · ALCON PHARMS LTD
- 2007KETOTIFEN FUMARATEGeneric (ANDA)
ANDA 077958 · SENTISS
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.
