FDA.reportPublic FDA data

Application 021996

Type
NDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALAWAYKETOTIFEN FUMARATESOLUTION/DROPS;OPHTHALMICEQ 0.025% BASEYesYes
002ALAWAYKETOTIFEN FUMARATESOLUTION/DROPS;OPHTHALMICEQ 0.035% BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0038Eye Itch Reliefketotifen fumarateWalgreen CompanyNDACurrent
0363-0038Eye Itch Reliefketotifen fumarateWalgreen CompanyNDACurrent
0363-0038Eye Itch Reliefketotifen fumarateWalgreen CompanyNDACurrent
0363-0038Eye Itch Reliefketotifen fumarateWalgreen CompanyNDACurrent
0536-1252Ketotifen FumarateKetotifen FumarateRugby LaboratoriesNDA AUTHORIZED GENERICCurrent
11673-064Eye Itch Reliefketotifen fumarateTarget CorporationNDACurrent
11673-064Eye Itch Reliefketotifen fumarateTarget CorporationNDACurrent
11673-064Eye Itch Reliefketotifen fumarateTarget CorporationNDACurrent
11822-5533Eye Itch ReleifKetotifen FumarateRite Aid CorporationNDACurrent
21130-601Eye Itch ReliefKetotifen FumarateSafewayNDACurrent
21130-601Eye Itch ReliefKetotifen FumarateSafewayNDACurrent
21130-601Eye Itch ReliefKetotifen FumarateSafewayNDACurrent
24208-601AlawayKetotifen FumarateBausch & Lomb IncorporatedNDACurrent
24208-601AlawayKetotifen FumarateBausch & Lomb IncorporatedNDACurrent
24208-601AlawayKetotifen FumarateBausch & Lomb IncorporatedNDACurrent
24208-601AlawayKetotifen FumarateBausch & Lomb IncorporatedNDACurrent
24208-601AlawayKetotifen FumarateBausch & Lomb IncorporatedNDACurrent
24208-601AlawayKetotifen FumarateBausch & Lomb IncorporatedNDACurrent
24208-601AlawayKetotifen FumarateBausch & Lomb IncorporatedNDACurrent
24208-901AlawayKetotifen FumarateBausch & Lomb IncorporatedNDACurrent
24208-901AlawayKetotifen FumarateBausch & Lomb IncorporatedNDACurrent
30142-398Eye Itch Reliefketotifen fumarateKroger CompanyNDACurrent
36800-097Eye Itch Reliefketotifen fumarateTOPCO ASSOCIATES LLCNDACurrent
49035-231Equate Eye Itch Reliefketotifen fumarateWal-Mart Stores, Inc.NDACurrent
49035-231Equate Eye Itch Reliefketotifen fumarateWal-Mart Stores, Inc.NDACurrent
69842-275Eye Itch ReliefKetotifen FumarateCVS PharmacyNDACurrent
70000-0522Eye Itch Reliefketotifen fumarateCardinal HealthNDACurrent
70000-0522Eye Itch Reliefketotifen fumarateCardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67086SUPPL2021-04-16
16723SUPPL2015-02-17
6638SUPPL2015-02-12
42376ORIG2008-10-03
29023SUPPL2007-04-25
38044SUPPL2007-04-20
6637ORIG2006-12-28