01 1ALCON PHARMA
02 1ALCON PHARMS LTD
03 1APOTEX INC
04 2BAUSCH AND LOMB
05 1BAUSCH AND LOMB INC
06 1BAYSHORE PHARMS LLC
07 1JOHNSON JOHNSON VISN
08 1SENTISS
01 1DRUG-ELUTING CONTACT LENS;OPHTHALMIC
02 8SOLUTION/DROPS;OPHTHALMIC
01 2DISCN
02 7OTC
01 1ACUVUE THERAVISION WITH KETOTIFEN
02 2ALAWAY
03 1CHILDRENS ALAWAY
04 3KETOTIFEN FUMARATE
05 2ZADITOR
01 5No
02 4Yes
RLD : Yes
TE Code :
Brand Name : ZADITOR
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2006-10-19
Application Number : 21066
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : ZADITOR
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.025% BASE
Approval Date : 2008-09-02
Application Number : 77200
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : KETOTIFEN FUMARATE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.025% BASE
Approval Date : 2006-05-09
Application Number : 77354
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : ALAWAY
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.025% BASE
Approval Date : 2006-12-01
Application Number : 21996
RX/OTC/DISCN : OTC
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : CHILDRENS ALAWAY
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.025% BASE
Approval Date : 2015-02-11
Application Number : 21996
RX/OTC/DISCN : OTC
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : ALAWAY
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.025% BASE
Approval Date : 2020-09-24
Application Number : 208158
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : KETOTIFEN FUMARATE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.025% BASE
Approval Date : 2020-06-01
Application Number : 204059
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : ACUVUE THERAVISION WITH KETOTIFEN
Dosage Form : DRUG-ELUTING CONTACT LENS;OPHTHALMIC
Dosage Strength : EQ 19MCG BASE
Approval Date : 2022-02-25
Application Number : 22388
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : KETOTIFEN FUMARATE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.025% BASE
Approval Date : 2007-07-26
Application Number : 77958
RX/OTC/DISCN : OTC
RLD : No
TE Code :
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