Application 077958

Type: ANDA
Sponsor: AKORN

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
A077958-001	KETOTIFEN FUMARATE	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC			2007-07-26

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 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	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077958-001	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2007-07-26	`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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketotifen Fumarate Ophthalmic Solution	KETOTIFEN FUMARATE	Sentiss Pharmaceuticals LLC	7e7be193-63ec-474d-a596-e22fc8b1be0f	2026-04-15	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958
Ketotifen Fumarate Ophthalmic Solution	KETOTIFEN FUMARATE	Preferred Pharmaceuticals Inc.	f4dd2b53-c2f2-4c5a-8eb0-c96d79cf419c	2026-03-18	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958
Eye Itch Relief	KETOTIFEN FUMARATE	CARDINAL HEALTH 110, LLC. DBA LEADER	add414c5-b6c5-4bb5-8d8a-ddc507a27131	2025-09-12	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958
Ketotifen Fumarate Ophthalmic Solution	KETOTIFEN FUMARATE	Armas Pharmaceuticals Inc.	b1ea15a5-5354-4086-a22d-cc1b3e0e1eb3	2024-01-01	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958
Ketotifen Fumarate	KETOTIFEN FUMARATE	Proficient Rx LP	3a9e70ab-d188-488c-8c47-a2184eb4ef2c	2019-10-01	Warnings	Exact identifier application applno (ANDA): 077958 application number: ANDA077958

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0179-8601	Ketotifen Fumarate	Ketotifen Fumarate	KAISER FOUNDATION HOSPITALS	ANDA	Current
0179-8601	Ketotifen Fumarate	Ketotifen Fumarate	KAISER FOUNDATION HOSPITALS	ANDA	Current
0363-0610	EYE ITCH RELIEF	Ketotifen Fumarate	Walgreens	ANDA	Current
0363-9060	Ketotifen Fumarate	Ketotifen Fumarate	Walgreens	ANDA	Current
0363-9060	Ketotifen Fumarate	Ketotifen Fumarate	Walgreens	ANDA	Current
0363-9060	Ketotifen Fumarate	Ketotifen Fumarate	Walgreens	ANDA	Current
0363-9060	Ketotifen Fumarate	Ketotifen Fumarate	Walgreens	ANDA	Current
0536-1096	Eye Itch Relief	Ketotifen Fumarate	Rugby Laboratories	ANDA	Current
0536-1096	Eye Itch Relief	Ketotifen Fumarate	Rugby Laboratories	ANDA	Current
0536-1096	Eye Itch Relief	Ketotifen Fumarate	Rugby Laboratories	ANDA	Current
0536-1096	Eye Itch Relief	Ketotifen Fumarate	Rugby Laboratories	ANDA	Current
11822-4201	eye itch relief	ketotifen fumarate	Rite Aid Corporation	ANDA	Current
11822-4201	eye itch relief	ketotifen fumarate	Rite Aid Corporation	ANDA	Current
11822-4201	eye itch relief	ketotifen fumarate	Rite Aid Corporation	ANDA	Current
11822-4201	eye itch relief	ketotifen fumarate	Rite Aid Corporation	ANDA	Current
11822-4202	eye itch relief	ketotifen fumarate	Rite Aid Corporation	ANDA	Current
11822-4202	eye itch relief	ketotifen fumarate	Rite Aid Corporation	ANDA	Current
11822-4202	eye itch relief	ketotifen fumarate	Rite Aid Corporation	ANDA	Current
11822-4202	eye itch relief	ketotifen fumarate	Rite Aid Corporation	ANDA	Current
17478-717	Ketotifen Fumarate	Ketotifen Fumarate	Akorn	ANDA	Current
17478-717	Ketotifen Fumarate	Ketotifen Fumarate	Akorn	ANDA	Current
17478-717	Ketotifen Fumarate	Ketotifen Fumarate	Akorn, Inc.	ANDA	Current
17478-717	Ketotifen Fumarate	Ketotifen Fumarate	Akorn, Inc.	ANDA	Current
17478-717	Ketotifen Fumarate	Ketotifen Fumarate	Akorn, Inc.	ANDA	Current
17478-717	Ketotifen Fumarate	Ketotifen Fumarate	Akorn	ANDA	Current
30142-702	Eye Itch	Ketotifen Fumarate	Kroger Company	ANDA	Current
30142-702	Eye Itch	Ketotifen Fumarate	Kroger Company	ANDA	Current
30142-702	Eye Itch	Ketotifen Fumarate	Kroger Company	ANDA	Current
30142-702	Eye Itch	Ketotifen Fumarate	Kroger Company	ANDA	Current
30142-770	Itchy Eye	Ketotifen Fumarate	Kroger Company	ANDA	Current
37808-802	Eye Itch Relief	Ketotifen Fumarate	H E B	ANDA	Current
37808-802	Eye Itch Relief	Ketotifen Fumarate	H E B	ANDA	Current
37808-802	Eye Itch Relief	Ketotifen Fumarate	H E B	ANDA	Current
37808-802	Eye Itch Relief	Ketotifen Fumarate	H E B	ANDA	Current
37808-870	Allergy Eye Drops	Ketotifen Fumarate	H E B	ANDA	Current
37808-870	Allergy Eye Drops	Ketotifen Fumarate	H E B	ANDA	Current
37808-870	Allergy Eye Drops	Ketotifen Fumarate	H E B	ANDA	Current
37808-870	Allergy Eye Drops	Ketotifen Fumarate	H E B	ANDA	Current
41250-302	Eye Itch	Ketotifen Fumarate	Meijer Distribution Inc	ANDA	Current
41250-302	Eye Itch	Ketotifen Fumarate	Meijer Distribution Inc	ANDA	Current
41250-302	Eye Itch	Ketotifen Fumarate	Meijer Distribution Inc	ANDA	Current
41250-302	Eye Itch	Ketotifen Fumarate	Meijer Distribution Inc	ANDA	Current
41250-302	Eye Itch	Ketotifen Fumarate	Meijer Distribution Inc	ANDA	Current
41250-303	Itchy Eye	Ketotifen Fumarate	Meijer Distribution Inc	ANDA	Current
41250-303	Itchy Eye	Ketotifen Fumarate	Meijer Distribution Inc	ANDA	Current
41250-303	Itchy Eye	Ketotifen Fumarate	Meijer Distribution Inc	ANDA	Current
41250-303	Itchy Eye	Ketotifen Fumarate	Meijer Distribution Inc	ANDA	Current
41250-870	Itchy Eye	Ketotifen Fumarate	Meijer Distribution Inc	ANDA	Current
46122-146	Itchy Eye Drops	ketotifen fumarate	Amerisource Bergen	ANDA	Current
46122-163	Eye Itch Relief	ketotifen fumarate	Amerisource Bergen	ANDA	Current
49348-107	eye itch relief	ketotifen fumarate	STRATEGIC SOURCING SERVICES LLC	ANDA	Current
49348-107	eye itch relief	ketotifen fumarate	STRATEGIC SOURCING SERVICES LLC	ANDA	Current
49348-107	eye itch relief	ketotifen fumarate	STRATEGIC SOURCING SERVICES LLC	ANDA	Current
49348-107	eye itch relief	ketotifen fumarate	STRATEGIC SOURCING SERVICES LLC	ANDA	Current
49348-107	eye itch relief	ketotifen fumarate	McKesson Corporation Valu-Rite	ANDA	Current
49781-075	Eye Itch Relief	Ketotifen Fumarate	Cardinal Health	ANDA	Current
49781-078	Allergy Eye Drops	Ketotifen Fumarate	Cardinal Health	ANDA	Current
50090-2900	Ketotifen Fumarate	Ketotifen Fumarate	A-S Medication Solutions	ANDA	Current
50090-2900	Ketotifen Fumarate	Ketotifen Fumarate	A-S Medication Solutions	ANDA	Current
50804-302	Eye Itch Relief	Ketotifen Fumarate	Good Sense	ANDA	Current
50804-392	Itchy Eye Drops	Ketotifen Fumarate	Good Sense	ANDA	Current
58790-008	Ketotifen Fumarate	Ketotifen Fumarate	Advanced Vision Research (Subsidiary of Akorn, Inc.)	ANDA	Current
58790-301	Allergy Eye Drops	Ketotifen Fumarate	Advanced Vision Research (Subsidiary of Akorn, Inc.)	ANDA	Current
59779-330	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-330	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-330	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-330	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-330	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-330	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-330	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-330	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-627	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-627	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-627	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-627	Ketotifen Fumarate	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-705	Eye Itch Relief	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-705	Eye Itch Relief	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-705	Eye Itch Relief	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-705	Eye Itch Relief	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current
59779-920	Eye Itch Relief	Ketotifen Fumarate	CVS Pharmacy	ANDA	Current