Application 214645

Type: ANDA
Sponsor: GLAND PHARMA LTD

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 42.

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
A214645-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB		2022-06-24
A214645-002	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB		2023-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214645-001	AB
A214645-002	AB

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 · 53 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
2026-08-18 06:07:40	2026-07	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214645-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2022-06-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214645-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	2023-02-14	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214645-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214645-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214645-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214645-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214645-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214645-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214645-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214645-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214645-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214645-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214645-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214645-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214645-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214645-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214645-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214645-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214645-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214645-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214645-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214645-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214645-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214645-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214645-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214645-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214645-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214645-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214645-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214645-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214645-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214645-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214645-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214645-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214645-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214645-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214645-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214645-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214645-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214645-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214645-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214645-002	AB	1	`9b2671bbb829…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Timolol Maleate	TIMOLOL MALEATE	Sagent Pharmaceuticals	272bb565-f099-4896-b2f6-48ab9180e941	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214645 application number: ANDA214645
Timolol Maleate Ophthalmic Gel Forming Solution	TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION	FOSUN PHARMA USA INC	e93036c6-3120-e989-e053-2a95a90acf7f	2023-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214645 application number: ANDA214645 ndc (product): 72266-199
timolol maleate ophthalmic gel forming solution	TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION	Gland Pharma Limited	79730e4f-d533-42c7-b7b6-cdbc47242baa	2023-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214645 application number: ANDA214645 ndc (product): 68083-457

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68083-457	Timolol Maleate Ophthalmic Gel Forming Solution	Timolol Maleate Ophthalmic Gel Forming Solution	Gland Pharma Limited	ANDA	Current
72266-199	Timolol Maleate Ophthalmic Gel Forming Solution	Timolol Maleate Ophthalmic Gel Forming Solution	FOSUN PHARMA USA INC	ANDA	Current