Application 208158

Type: ANDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALAWAY	KETOTIFEN FUMARATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.035% 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
A208158-001	ALAWAY	KETOTIFEN FUMARATE	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC			2020-09-24

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.

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	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208158-001	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208158-001	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208158-001	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208158-001	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208158-001	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208158-001	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208158-001	ALAWAY	EQ 0.035% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208158-001	ALAWAY	EQ 0.025% BASE	SOLUTION/DROPS / OPHTHALMIC	2020-09-24	`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 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 brand name: Alaway 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 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24208-600	Alaway Preservative Free	ketotifen fumarate	Bausch & Lomb Incorporated	ANDA	Current
24208-600	Alaway Preservative Free	ketotifen fumarate	Bausch & Lomb Incorporated	ANDA	Current
24208-600	Alaway Preservative Free	ketotifen fumarate	Bausch & Lomb Incorporated	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65090	ORIG	2020-10-30