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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077354-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2006-05-09	`caaa826d4ba7…`
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…`

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alaway	KETOTIFEN FUMARATE	Bausch & Lomb Incorporated	e4c310b5-1dba-4ddc-bc90-b27ebc765871	2022-05-01	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Equate Eye Itch Relief	KETOTIFEN FUMARATE	Wal-Mart Stores, Inc.	accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9	2021-03-23	Warnings	Name fallback generic name: KETOTIFEN FUMARATE
Ketotifen Fumarate	KETOTIFEN FUMARATE	Proficient Rx LP	3a9e70ab-d188-488c-8c47-a2184eb4ef2c	2019-10-01	Warnings	Name fallback brand name: Ketotifen Fumarate generic name: KETOTIFEN FUMARATE

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 · 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