Orange Book product · Generic (ANDA)
KETOTIFEN FUMARATE
KETOTIFEN FUMARATE
At a glance
Jun 01, 2020
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 01, 2020
6 yr 2 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 204059
Product number
001
Marketing status
OTC
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
- 2008ZADITORGeneric (ANDA)
ANDA 077200 · ALCON PHARMS LTD
- 2007KETOTIFEN FUMARATEGeneric (ANDA)
ANDA 077958 · SENTISS
- 2006KETOTIFEN FUMARATEGeneric (ANDA)
ANDA 077354 · APOTEX INC
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.
