Application 077354

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.025% BASE	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077354-001	KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC			2006-05-09

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`cb3db0bc1861…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eye Itch Relief	KETOTIFEN FUMARATE	Redpharm Drug	52c62397-58f1-d34d-e063-6294a90a6faf	2026-05-27	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Ketotifen Fumarate	KETOTIFEN FUMARATE	Preferred Pharmaceuticals Inc.	5196ec5b-42d9-40db-a77a-c00360b8cee6	2026-05-15	Warnings	Name fallback brand name: Ketotifen Fumarate generic name: KETOTIFEN FUMARATE
Ketotifen Fumarate Ophthalmic Solution	KETOTIFEN FUMARATE	Sentiss Pharmaceuticals LLC	7e7be193-63ec-474d-a596-e22fc8b1be0f	2026-04-15	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Eye Itch Relief	KETOTIFEN FUMARATE	Walgreen Company	9ce8f926-c202-40d1-9dba-0477f1f49e14	2026-03-25	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Ketotifen Fumarate	KETOTIFEN FUMARATE	Rugby Laboratories	8aa81ae9-112a-49fa-a0cb-ed0217a40de5	2026-03-20	Warnings	Name fallback brand name: Ketotifen Fumarate generic name: KETOTIFEN FUMARATE
Ketotifen Fumarate Ophthalmic Solution	KETOTIFEN FUMARATE	Preferred Pharmaceuticals Inc.	f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c	2026-03-18	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Eye Itch Relief	KETOTIFEN FUMARATE	CVS Pharmacy	7d0146a9-5073-4e24-954f-75b84affadc2	2026-01-15	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Eye Itch Relief	KETOTIFEN FUMARATE	PERRIGO DIRECT INC.	d3049296-0d15-4523-883c-25f8817bc735	2026-01-15	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	Unichem Pharmaceuticals (USA), Inc.	0fe119ad-cb44-4e90-a096-0ed0ba63dc31	2025-11-24		Name fallback brand name: KETOTIFEN FUMARATE generic name: KETOTIFEN FUMARATE
Eye Itch Relief	KETOTIFEN FUMARATE	CARDINAL HEALTH 110, LLC. DBA LEADER	add414c5-b6c5-4bb5-8d8a-ddc507a27131	2025-09-12	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Eye Itch Relief	KETOTIFEN FUMARATE	Target Corporation	b25106f8-436e-4c06-8780-b12368ede9fe	2025-03-28	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Eye Itch Relief	KETOTIFEN FUMARATE	A-S Medication Solutions	b0eb7b54-4f4e-4ca2-8e4e-30d18d662401	2024-10-01	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Eye Itch Releif	KETOTIFEN FUMARATE	Rite Aid Corporation	6a7be1e9-27ff-44d8-85ed-fc1b0017180e	2024-07-22	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Eye Itch Relief	KETOTIFEN FUMARATE	Safeway	5fccbb63-7859-484c-b7b3-9de711364c09	2024-05-16	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Ketotifen Fumarate Ophthalmic Solution	KETOTIFEN FUMARATE	Armas Pharmaceuticals Inc.	b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3	2024-01-01	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Zaditor	KETOTIFEN FUMARATE	Alcon Laboratories, Inc.	ac66b1e4-c2b0-a4c3-09e3-ebd44a2f7c9f	2023-12-15	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Eye Itch Relief	KETOTIFEN FUMARATE	Cardinal Health	e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8	2023-12-08	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Eye Itch Relief	KETOTIFEN FUMARATE	TOPCO ASSOCIATES LLC	b723daa3-6c6f-4a96-a15d-0d5866f28ca4	2023-12-08	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Eye Itch Relief	KETOTIFEN FUMARATE	Kroger Company	eb81286f-72b4-42b3-a596-439d0aeae93f	2023-12-08	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Ketotifen Fumarate	KETOTIFEN FUMARATE	A-S Medication Solutions	1234de19-257c-422c-8706-1239381a2706	2023-05-11	Warnings	Name fallback brand name: Ketotifen Fumarate generic name: KETOTIFEN FUMARATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0536-1222	Ketotifen Fumarate	Ketotifen Fumarate	Rugby Laboratories	ANDA	Current
46122-304	Ketotifen Fumarate	Ketotifen Fumarate	AMERISOURCEBERGEN DRUG CORPORATION	ANDA	Current
46122-634	Ketotifen Fumarate	Ketotifen Fumarate	AMERISOURCEBERGEN DRUG CORPORATION	ANDA	Current
60505-6215	Ketotifen Fumarate	Ketotifen Fumarate	Apotex Corp.	ANDA	Current
60505-6215	Ketotifen Fumarate	Ketotifen Fumarate	Apotex Corp.	ANDA	Current
60505-6215	Ketotifen Fumarate	Ketotifen Fumarate	Apotex Corp.	ANDA	Current
62011-0379	Ketotifen Fumarate	Ketotifen Fumarate	Stategic Sourcing Services LLC	ANDA	Current
62011-0379	Ketotifen Fumarate	Ketotifen Fumarate	Stategic Sourcing Services LLC	ANDA	Current
62011-0379	Ketotifen Fumarate	Ketotifen Fumarate	McKesson (Healthmart)	ANDA	Current
62011-0379	Ketotifen Fumarate	Ketotifen Fumarate	McKesson (Healthmart)	ANDA	Current
62011-0379	Ketotifen Fumarate	Ketotifen Fumarate	Stategic Sourcing Services LLC	ANDA	Current
69842-600	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
69842-601	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
70518-2867	Ketotifen Fumarate	Ketotifen Fumarate	REMEDYREPACK INC.	ANDA	Current
70518-2867	Ketotifen Fumarate	Ketotifen Fumarate	REMEDYREPACK INC.	ANDA	Current
70677-0052	Ketotifen Fumarate	Ketotifen Fumarate	McKesson (Sunmark)	ANDA	Current
70677-0052	Ketotifen Fumarate	Ketotifen Fumarate	Strategic Sourcing Services LLC	ANDA	Current
70677-0052	Ketotifen Fumarate	Ketotifen Fumarate	Strategic Sourcing Services LLC	ANDA	Current
70677-0052	Ketotifen Fumarate	Ketotifen Fumarate	McKesson (Sunmark)	ANDA	Current
70677-0052	Ketotifen Fumarate	Ketotifen Fumarate	Strategic Sourcing Services LLC	ANDA	Current
72189-114	KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	DIRECT RX	ANDA	Current
72189-114	KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	DIRECT RX	ANDA	Current
72189-114	KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	DIRECT RX	ANDA	Current