FDA.reportPublic FDA data

Application 077958

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KETOTIFEN FUMARATEKETOTIFEN FUMARATESOLUTION/DROPS;OPHTHALMICEQ 0.025% BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077958-001KETOTIFEN FUMARATEKETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077958-001KETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2007-07-26a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketotifen Fumarate Ophthalmic SolutionKETOTIFEN FUMARATESentiss Pharmaceuticals LLC7e7be193-63ec-474d-a596-e22fc8b1be0f2026-04-15WarningsExact identifier
application applno (ANDA): 077958
application number: ANDA077958
Ketotifen Fumarate Ophthalmic SolutionKETOTIFEN FUMARATEPreferred Pharmaceuticals Inc.f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c2026-03-18WarningsExact identifier
application applno (ANDA): 077958
application number: ANDA077958
Eye Itch ReliefKETOTIFEN FUMARATECARDINAL HEALTH 110, LLC. DBA LEADERadd414c5-b6c5-4bb5-8d8a-ddc507a271312025-09-12WarningsExact identifier
application applno (ANDA): 077958
application number: ANDA077958
Ketotifen Fumarate Ophthalmic SolutionKETOTIFEN FUMARATEArmas Pharmaceuticals Inc.b1ea15a5-5354-4086-a22d-cc1b3e0e1eb32024-01-01WarningsExact identifier
application applno (ANDA): 077958
application number: ANDA077958
Ketotifen FumarateKETOTIFEN FUMARATEProficient Rx LP3a9e70ab-d188-488c-8c47-a2184eb4ef2c2019-10-01WarningsExact identifier
application applno (ANDA): 077958
application number: ANDA077958

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 106 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-8601Ketotifen FumarateKetotifen FumarateKAISER FOUNDATION HOSPITALSANDACurrent
0179-8601Ketotifen FumarateKetotifen FumarateKAISER FOUNDATION HOSPITALSANDACurrent
0363-0610EYE ITCH RELIEFKetotifen FumarateWalgreensANDACurrent
0363-9060Ketotifen FumarateKetotifen FumarateWalgreensANDACurrent
0363-9060Ketotifen FumarateKetotifen FumarateWalgreensANDACurrent
0363-9060Ketotifen FumarateKetotifen FumarateWalgreensANDACurrent
0363-9060Ketotifen FumarateKetotifen FumarateWalgreensANDACurrent
0536-1096Eye Itch ReliefKetotifen FumarateRugby LaboratoriesANDACurrent
0536-1096Eye Itch ReliefKetotifen FumarateRugby LaboratoriesANDACurrent
0536-1096Eye Itch ReliefKetotifen FumarateRugby LaboratoriesANDACurrent
0536-1096Eye Itch ReliefKetotifen FumarateRugby LaboratoriesANDACurrent
11822-4201eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4201eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4201eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4201eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4202eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4202eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4202eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
11822-4202eye itch reliefketotifen fumarateRite Aid CorporationANDACurrent
17478-717Ketotifen FumarateKetotifen FumarateAkornANDACurrent
17478-717Ketotifen FumarateKetotifen FumarateAkornANDACurrent
17478-717Ketotifen FumarateKetotifen FumarateAkorn, Inc.ANDACurrent
17478-717Ketotifen FumarateKetotifen FumarateAkorn, Inc.ANDACurrent
17478-717Ketotifen FumarateKetotifen FumarateAkorn, Inc.ANDACurrent
17478-717Ketotifen FumarateKetotifen FumarateAkornANDACurrent
30142-702Eye ItchKetotifen FumarateKroger CompanyANDACurrent
30142-702Eye ItchKetotifen FumarateKroger CompanyANDACurrent
30142-702Eye ItchKetotifen FumarateKroger CompanyANDACurrent
30142-702Eye ItchKetotifen FumarateKroger CompanyANDACurrent
30142-770Itchy EyeKetotifen FumarateKroger CompanyANDACurrent
37808-802Eye Itch ReliefKetotifen FumarateH E BANDACurrent
37808-802Eye Itch ReliefKetotifen FumarateH E BANDACurrent
37808-802Eye Itch ReliefKetotifen FumarateH E BANDACurrent
37808-802Eye Itch ReliefKetotifen FumarateH E BANDACurrent
37808-870Allergy Eye DropsKetotifen FumarateH E BANDACurrent
37808-870Allergy Eye DropsKetotifen FumarateH E BANDACurrent
37808-870Allergy Eye DropsKetotifen FumarateH E BANDACurrent
37808-870Allergy Eye DropsKetotifen FumarateH E BANDACurrent
41250-302Eye ItchKetotifen FumarateMeijer Distribution IncANDACurrent
41250-302Eye ItchKetotifen FumarateMeijer Distribution IncANDACurrent
41250-302Eye ItchKetotifen FumarateMeijer Distribution IncANDACurrent
41250-302Eye ItchKetotifen FumarateMeijer Distribution IncANDACurrent
41250-302Eye ItchKetotifen FumarateMeijer Distribution IncANDACurrent
41250-303Itchy EyeKetotifen FumarateMeijer Distribution IncANDACurrent
41250-303Itchy EyeKetotifen FumarateMeijer Distribution IncANDACurrent
41250-303Itchy EyeKetotifen FumarateMeijer Distribution IncANDACurrent
41250-303Itchy EyeKetotifen FumarateMeijer Distribution IncANDACurrent
41250-870Itchy EyeKetotifen FumarateMeijer Distribution IncANDACurrent
46122-146Itchy Eye Dropsketotifen fumarateAmerisource BergenANDACurrent
46122-163Eye Itch Reliefketotifen fumarateAmerisource BergenANDACurrent
49348-107eye itch reliefketotifen fumarateSTRATEGIC SOURCING SERVICES LLCANDACurrent
49348-107eye itch reliefketotifen fumarateSTRATEGIC SOURCING SERVICES LLCANDACurrent
49348-107eye itch reliefketotifen fumarateSTRATEGIC SOURCING SERVICES LLCANDACurrent
49348-107eye itch reliefketotifen fumarateSTRATEGIC SOURCING SERVICES LLCANDACurrent
49348-107eye itch reliefketotifen fumarateMcKesson Corporation Valu-RiteANDACurrent
49781-075Eye Itch ReliefKetotifen FumarateCardinal HealthANDACurrent
49781-078Allergy Eye DropsKetotifen FumarateCardinal HealthANDACurrent
50090-2900Ketotifen FumarateKetotifen FumarateA-S Medication SolutionsANDACurrent
50090-2900Ketotifen FumarateKetotifen FumarateA-S Medication SolutionsANDACurrent
50804-302Eye Itch ReliefKetotifen FumarateGood SenseANDACurrent
50804-392Itchy Eye DropsKetotifen FumarateGood SenseANDACurrent
58790-008Ketotifen FumarateKetotifen FumarateAdvanced Vision Research (Subsidiary of Akorn, Inc.)ANDACurrent
58790-301Allergy Eye DropsKetotifen FumarateAdvanced Vision Research (Subsidiary of Akorn, Inc.)ANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-330Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-627Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-627Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-627Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-627Ketotifen FumarateKetotifen FumarateCVS PharmacyANDACurrent
59779-705Eye Itch ReliefKetotifen FumarateCVS PharmacyANDACurrent
59779-705Eye Itch ReliefKetotifen FumarateCVS PharmacyANDACurrent
59779-705Eye Itch ReliefKetotifen FumarateCVS PharmacyANDACurrent
59779-705Eye Itch ReliefKetotifen FumarateCVS PharmacyANDACurrent
59779-920Eye Itch ReliefKetotifen FumarateCVS PharmacyANDACurrent