Application 216533

Type: ANDA
Sponsor: INGENUS PHARMS LLC

Application Products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216533-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3		2022-09-13
A216533-002	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3		2022-09-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A216533-001	AT3
A216533-002	AT3

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 · 52 observed 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
2026-02-19 14:30 UTC	2026-02	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216533-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216533-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT3	2022-09-13	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216533-001	AT3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216533-002	AT3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216533-001	AT3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216533-002	AT3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216533-001	AT3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216533-002	AT3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216533-001	AT3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216533-002	AT3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216533-001	AT3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216533-002	AT3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216533-001	AT3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216533-002	AT3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216533-001	AT3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216533-002	AT3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216533-001	AT3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216533-002	AT3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216533-001	AT3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216533-002	AT3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216533-001	AT3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216533-002	AT3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216533-001	AT3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216533-002	AT3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216533-001	AT3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216533-002	AT3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216533-001	AT3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216533-002	AT3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216533-001	AT3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216533-002	AT3	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216533-001	AT3	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216533-002	AT3	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216533-001	AT3	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216533-002	AT3	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216533-001	AT3	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216533-002	AT3	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216533-001	AT3	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216533-002	AT3	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216533-001	AT3	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216533-002	AT3	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216533-001	AT3	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216533-002	AT3	1	`a67488948f0b…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Timolol Maleate	TIMOLOL MALEATE	Ingenus Pharmaceuticals, LLC	4c4318b3-9865-4172-a7bd-9e68913eca1e	2023-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216533 application number: ANDA216533 ndc (product): 50742-287 ndc (product): 50742-288

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50742-287	Timolol Maleate	timolol maleate	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-287	Timolol Maleate	timolol maleate	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-288	Timolol Maleate	timolol maleate	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-288	Timolol Maleate	timolol maleate	Ingenus Pharmaceuticals, LLC	ANDA	Current