FDA.reportPublic FDA data

Application 208158

Type
ANDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALAWAYKETOTIFEN FUMARATESOLUTION/DROPS;OPHTHALMICEQ 0.035% BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A208158-001ALAWAYKETOTIFEN FUMARATEEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208158-001ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMIC2020-09-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A208158-001ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208158-001ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208158-001ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMIC2020-09-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A208158-001ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMIC2020-09-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208158-001ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMIC2020-09-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208158-001ALAWAYEQ 0.035% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208158-001ALAWAYEQ 0.025% BASESOLUTION/DROPS / OPHTHALMIC2020-09-24a50c72e98297…

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye Itch ReliefKETOTIFEN FUMARATERedpharm Drug52c62397-58f1-d34d-e063-6294a90a6faf2026-05-27WarningsName fallback
generic name: KETOTIFEN FUMARATE
Ketotifen FumarateKETOTIFEN FUMARATEPreferred Pharmaceuticals Inc.5196ec5b-42d9-40db-a77a-c00360b8cee62026-05-15WarningsName fallback
generic name: KETOTIFEN FUMARATE
Ketotifen Fumarate Ophthalmic SolutionKETOTIFEN FUMARATESentiss Pharmaceuticals LLC7e7be193-63ec-474d-a596-e22fc8b1be0f2026-04-15WarningsName fallback
generic name: KETOTIFEN FUMARATE
Eye Itch ReliefKETOTIFEN FUMARATEWalgreen Company9ce8f926-c202-40d1-9dba-0477f1f49e142026-03-25WarningsName fallback
generic name: KETOTIFEN FUMARATE
Ketotifen FumarateKETOTIFEN FUMARATERugby Laboratories8aa81ae9-112a-49fa-a0cb-ed0217a40de52026-03-20WarningsName fallback
generic name: KETOTIFEN FUMARATE
Ketotifen Fumarate Ophthalmic SolutionKETOTIFEN FUMARATEPreferred Pharmaceuticals Inc.f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c2026-03-18WarningsName fallback
generic name: KETOTIFEN FUMARATE
Eye Itch ReliefKETOTIFEN FUMARATECVS Pharmacy7d0146a9-5073-4e24-954f-75b84affadc22026-01-15WarningsName fallback
generic name: KETOTIFEN FUMARATE
Eye Itch ReliefKETOTIFEN FUMARATEPERRIGO DIRECT INC.d3049296-0d15-4523-883c-25f8817bc7352026-01-15WarningsName fallback
generic name: KETOTIFEN FUMARATE
KETOTIFEN FUMARATEKETOTIFEN FUMARATEUnichem Pharmaceuticals (USA), Inc.0fe119ad-cb44-4e90-a096-0ed0ba63dc312025-11-24Name fallback
generic name: KETOTIFEN FUMARATE
Eye Itch ReliefKETOTIFEN FUMARATECARDINAL HEALTH 110, LLC. DBA LEADERadd414c5-b6c5-4bb5-8d8a-ddc507a271312025-09-12WarningsName fallback
generic name: KETOTIFEN FUMARATE
Eye Itch ReliefKETOTIFEN FUMARATETarget Corporationb25106f8-436e-4c06-8780-b12368ede9fe2025-03-28WarningsName fallback
generic name: KETOTIFEN FUMARATE
Eye Itch ReliefKETOTIFEN FUMARATEA-S Medication Solutionsb0eb7b54-4f4e-4ca2-8e4e-30d18d6624012024-10-01WarningsName fallback
generic name: KETOTIFEN FUMARATE
Eye Itch ReleifKETOTIFEN FUMARATERite Aid Corporation6a7be1e9-27ff-44d8-85ed-fc1b0017180e2024-07-22WarningsName fallback
generic name: KETOTIFEN FUMARATE
Eye Itch ReliefKETOTIFEN FUMARATESafeway5fccbb63-7859-484c-b7b3-9de711364c092024-05-16WarningsName fallback
generic name: KETOTIFEN FUMARATE
Ketotifen Fumarate Ophthalmic SolutionKETOTIFEN FUMARATEArmas Pharmaceuticals Inc.b1ea15a5-5354-4086-a22d-cc1b3e0e1eb32024-01-01WarningsName fallback
generic name: KETOTIFEN FUMARATE
ZaditorKETOTIFEN FUMARATEAlcon Laboratories, Inc.ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f2023-12-15WarningsName fallback
generic name: KETOTIFEN FUMARATE
Eye Itch ReliefKETOTIFEN FUMARATECardinal Healthe5fd1246-c4a7-4be3-a3d3-83d82ec6cab82023-12-08WarningsName fallback
generic name: KETOTIFEN FUMARATE
Eye Itch ReliefKETOTIFEN FUMARATETOPCO ASSOCIATES LLCb723daa3-6c6f-4a96-a15d-0d5866f28ca42023-12-08WarningsName fallback
generic name: KETOTIFEN FUMARATE
Eye Itch ReliefKETOTIFEN FUMARATEKroger Companyeb81286f-72b4-42b3-a596-439d0aeae93f2023-12-08WarningsName fallback
generic name: KETOTIFEN FUMARATE
Ketotifen FumarateKETOTIFEN FUMARATEA-S Medication Solutions1234de19-257c-422c-8706-1239381a27062023-05-11WarningsName fallback
generic name: KETOTIFEN FUMARATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-600Alaway Preservative Freeketotifen fumarateBausch & Lomb IncorporatedANDACurrent
24208-600Alaway Preservative Freeketotifen fumarateBausch & Lomb IncorporatedANDACurrent
24208-600Alaway Preservative Freeketotifen fumarateBausch & Lomb IncorporatedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65090ORIG2020-10-30