Orange Book product · Brand (NDA)
CHILDREN'S ALAWAY
KETOTIFEN FUMARATE
At a glance
Feb 11, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 11, 2015
11 yr 6 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
NDA 021996
Product number
002
Marketing status
OTC
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.
- 2022ACUVUE THERAVISION WITH KETOTIFENBrand (NDA)
NDA 022388 · JOHNSON JOHNSON VISN
- 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
- 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.
