Application 216343

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIMOLOL MALEATE	TIMOLOL MALEATE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	EQ 0.25% BASE	No	No
002	TIMOLOL MALEATE	TIMOLOL MALEATE	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	EQ 0.5% 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216343-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC			2024-05-23
A216343-002	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC			2024-05-23

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2024-05-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2024-05-23	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216343-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216343-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC		2024-05-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216343-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216343-002	AB	1	`1e350fbaab3a…`

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 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TIMOLOL MALEATE	TIMOLOL MALEATE	A-S Medication Solutions	64561dfd-3704-4820-aef6-d0d26cef7255	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: TIMOLOL MALEATE generic name: TIMOLOL MALEATE
Timoptic in Ocudose	TIMOLOL MALEATE	Nordic Pharma, Inc.	16323b0e-78ae-40e5-be93-04f698dd672b	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE	Sandoz Inc	f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea	2026-02-20	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE	Sagent Pharmaceuticals	272bb565-f099-4896-b2f6-48ab9180e941	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE	A-S Medication Solutions	7a1ea848-5b55-4038-afb1-029645ee0925	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
TIMOLOL MALEATE	TIMOLOL MALEATE	Rising Pharma Holdings, Inc.	2ed21930-1e05-46de-8acd-cb6f4798a7fa	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: TIMOLOL MALEATE generic name: TIMOLOL MALEATE
Timolol maleate	TIMOLOL MALEATE	Armas Pharmaceuticals, Inc.	ea585fe8-3356-4f08-8078-34e8ab5de37e	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Timolol maleate generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE	Bausch & Lomb Americas Inc.	581f80f7-4419-49e2-867d-40443c75409f	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE	Bausch & Lomb Americas Inc.	036dc753-1698-4c69-9bcf-752c7061203c	2025-03-05	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE	Bausch & Lomb Americas Inc.	9c14ca2d-80f3-48ef-b99a-beafaa728a24	2025-03-04	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE	A-S Medication Solutions	5305a38e-d9c8-4f9e-bf67-b246abc82cb1	2024-12-20	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE	Micro Labs Limited	79b223e4-d929-4667-8149-e79bfab13fdf	2024-12-05	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE	Bausch & Lomb Americas Inc.	b686bbad-1ef7-4b94-a316-4d182a40b89a	2024-11-04	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE	Somerset Therapeutics, LLC	e797f7c7-0588-4627-b060-8df6bcfe3f7b	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
Istalol	TIMOLOL MALEATE	Bausch & Lomb Incorporated	258bbc8d-00ee-45b0-ac35-6f16c4e8d45f	2024-10-30	Warnings, Adverse reactions	Name fallback generic name: TIMOLOL MALEATE
TIMOLOL MALEATE	TIMOLOL MALEATE	Leading Pharma, LLC	d6fa2971-dacf-42ab-99bc-c7ce6013221e	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: TIMOLOL MALEATE generic name: TIMOLOL MALEATE
timolol maleate	TIMOLOL MALEATE	NorthStar RxLLC	9db7322d-eb31-4fff-9b14-8a0294d01704	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: timolol maleate generic name: TIMOLOL MALEATE
Timolol Maleate	TIMOLOL MALEATE OPHTHALMIC	Micro Labs Limited	6c9f3971-8c07-4d3a-915d-76438baa2a0b	2024-10-03	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate
Timolol Maleate	TIMOLOL MALEATE	Caplin Steriles Limited	4847f180-45e6-40f0-ae8c-6cc500cb0add	2024-08-19	Warnings, Adverse reactions	Name fallback brand name: Timolol Maleate generic name: TIMOLOL MALEATE
Timolol maleate	TIMOLOL MALEATE	Somerset Therapeutics, LLC	5d60db57-ca24-4cab-a90d-8cf06992a34e	2024-07-04	Warnings, Adverse reactions	Name fallback brand name: Timolol maleate generic name: TIMOLOL MALEATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78840	ORIG	2024-06-20