Home Applications 021996 Application 021996
Type NDA
Sponsor BAUSCH AND LOMB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALAWAY KETOTIFEN FUMARATE SOLUTION/DROPS;OPHTHALMIC EQ 0.025% BASE Yes Yes 002 ALAWAY KETOTIFEN FUMARATE SOLUTION/DROPS;OPHTHALMIC EQ 0.035% BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021996-001 ALAWAY KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 N021996-002 CHILDREN'S ALAWAY KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11
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 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021996-001 ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2006-12-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021996-002 CHILDREN'S ALAWAY EQ 0.025% BASE SOLUTION/DROPS / OPHTHALMIC RLD 2015-02-11 a50c72e98297…
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 · 14 matching rows.
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 1 · 28 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-0038 Eye Itch Relief ketotifen fumarate Walgreen Company NDA Current 0363-0038 Eye Itch Relief ketotifen fumarate Walgreen Company NDA Current 0363-0038 Eye Itch Relief ketotifen fumarate Walgreen Company NDA Current 0363-0038 Eye Itch Relief ketotifen fumarate Walgreen Company NDA Current 0536-1252 Ketotifen Fumarate Ketotifen Fumarate Rugby Laboratories NDA AUTHORIZED GENERIC Current 11673-064 Eye Itch Relief ketotifen fumarate Target Corporation NDA Current 11673-064 Eye Itch Relief ketotifen fumarate Target Corporation NDA Current 11673-064 Eye Itch Relief ketotifen fumarate Target Corporation NDA Current 11822-5533 Eye Itch Releif Ketotifen Fumarate Rite Aid Corporation NDA Current 21130-601 Eye Itch Relief Ketotifen Fumarate Safeway NDA Current 21130-601 Eye Itch Relief Ketotifen Fumarate Safeway NDA Current 21130-601 Eye Itch Relief Ketotifen Fumarate Safeway NDA Current 24208-601 Alaway Ketotifen Fumarate Bausch & Lomb Incorporated NDA Current 24208-601 Alaway Ketotifen Fumarate Bausch & Lomb Incorporated NDA Current 24208-601 Alaway Ketotifen Fumarate Bausch & Lomb Incorporated NDA Current 24208-601 Alaway Ketotifen Fumarate Bausch & Lomb Incorporated NDA Current 24208-601 Alaway Ketotifen Fumarate Bausch & Lomb Incorporated NDA Current 24208-601 Alaway Ketotifen Fumarate Bausch & Lomb Incorporated NDA Current 24208-601 Alaway Ketotifen Fumarate Bausch & Lomb Incorporated NDA Current 24208-901 Alaway Ketotifen Fumarate Bausch & Lomb Incorporated NDA Current 24208-901 Alaway Ketotifen Fumarate Bausch & Lomb Incorporated NDA Current 30142-398 Eye Itch Relief ketotifen fumarate Kroger Company NDA Current 36800-097 Eye Itch Relief ketotifen fumarate TOPCO ASSOCIATES LLC NDA Current 49035-231 Equate Eye Itch Relief ketotifen fumarate Wal-Mart Stores, Inc. NDA Current 49035-231 Equate Eye Itch Relief ketotifen fumarate Wal-Mart Stores, Inc. NDA Current 69842-275 Eye Itch Relief Ketotifen Fumarate CVS Pharmacy NDA Current 70000-0522 Eye Itch Relief ketotifen fumarate Cardinal Health NDA Current 70000-0522 Eye Itch Relief ketotifen fumarate Cardinal Health NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 67086 SUPPL 2021-04-16 16723 SUPPL 2015-02-17 6638 SUPPL 2015-02-12 42376 ORIG 2008-10-03 29023 SUPPL 2007-04-25 38044 SUPPL 2007-04-20 6637 ORIG 2006-12-28