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 1.

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021996-002	CHILDREN'S ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021996-002	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021996-002	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021996-002	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021996-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2006-12-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021996-002	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD	2015-02-11	`782e0a99824c…`

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 · 15 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	Exact identifier application applno (NDA): 021996 application number: NDA021996
Eye Itch Relief	KETOTIFEN FUMARATE	Walgreen Company	9ce8f926-c202-40d1-9dba-0477f1f49e14	2026-03-25	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996 ndc (product): 0363-0038
Ketotifen Fumarate	KETOTIFEN FUMARATE	Rugby Laboratories	8aa81ae9-112a-49fa-a0cb-ed0217a40de5	2026-03-20	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996 ndc (product): 0536-1252
Eye Itch Relief	KETOTIFEN FUMARATE	CVS Pharmacy	7d0146a9-5073-4e24-954f-75b84affadc2	2026-01-15	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996 ndc (product): 69842-275
Eye Itch Relief	KETOTIFEN FUMARATE	PERRIGO DIRECT INC.	d3049296-0d15-4523-883c-25f8817bc735	2026-01-15	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Eye Itch Relief	KETOTIFEN FUMARATE	Target Corporation	b25106f8-436e-4c06-8780-b12368ede9fe	2025-03-28	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996 ndc (product): 11673-064
Eye Itch Relief	KETOTIFEN FUMARATE	A-S Medication Solutions	b0eb7b54-4f4e-4ca2-8e4e-30d18d662401	2024-10-01	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Eye Itch Releif	KETOTIFEN FUMARATE	Rite Aid Corporation	6a7be1e9-27ff-44d8-85ed-fc1b0017180e	2024-07-22	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996 ndc (product): 11822-5533
Eye Itch Relief	KETOTIFEN FUMARATE	Safeway	5fccbb63-7859-484c-b7b3-9de711364c09	2024-05-16	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996 ndc (product): 21130-601
Eye Itch Relief	KETOTIFEN FUMARATE	Cardinal Health	e5fd1246-c4a7-4be3-a3d3-83d82ec6cab8	2023-12-08	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996 ndc (product): 70000-0522
Eye Itch Relief	KETOTIFEN FUMARATE	TOPCO ASSOCIATES LLC	b723daa3-6c6f-4a96-a15d-0d5866f28ca4	2023-12-08	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996 ndc (product): 36800-097
Eye Itch Relief	KETOTIFEN FUMARATE	Kroger Company	eb81286f-72b4-42b3-a596-439d0aeae93f	2023-12-08	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996 ndc (product): 30142-398
Ketotifen Fumarate	KETOTIFEN FUMARATE	A-S Medication Solutions	1234de19-257c-422c-8706-1239381a2706	2023-05-11	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996
Alaway	KETOTIFEN FUMARATE	Bausch & Lomb Incorporated	e4c310b5-1dba-4ddc-bc90-b27ebc765871	2022-05-01	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996 ndc (product): 24208-601
Equate Eye Itch Relief	KETOTIFEN FUMARATE	Wal-Mart Stores, Inc.	accb5fe9-b3d0-4e2e-a3f0-e7d16873bbb9	2021-03-23	Warnings	Exact identifier application applno (NDA): 021996 application number: NDA021996 ndc (product): 49035-231

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