Application 212942

Type: ANDA
Sponsor: ALEMBIC PHARMS 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
A212942-001	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22
A212942-002	TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212942-001	AB
A212942-002	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 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212942-001	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212942-002	TIMOLOL MALEATE	EQ 0.5% BASE	SOLUTION, GEL FORMING/DROPS / OPHTHALMIC	AB	RS	2020-10-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A212942-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212942-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212942-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212942-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212942-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212942-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212942-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212942-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212942-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212942-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212942-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212942-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212942-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212942-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212942-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212942-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212942-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212942-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212942-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212942-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212942-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212942-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212942-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212942-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212942-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212942-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212942-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212942-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212942-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212942-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212942-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212942-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212942-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212942-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212942-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212942-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212942-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212942-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212942-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212942-002	AB	1	`782e0a99824c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A212942-001	CGT	2021-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212942-002	CGT	2021-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212942-001	CGT	2021-05-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212942-002	CGT	2021-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212942-001	CGT	2021-05-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A212942-002	CGT	2021-05-24	`5aa47cf7b7d7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%	TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25%	Alembic Pharmaceuticals Inc.	b909ecf0-c90a-4719-a144-9e74f457cb87	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212942 application number: ANDA212942 ndc (product): 62332-546 ndc (product): 62332-545
Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%	TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25%	Alembic Pharmaceuticals Limited	9a5aab8f-59b9-4d73-82c4-dc5b8fa8119e	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212942 application number: ANDA212942

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62332-545	Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%	Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-545	Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%	Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-545	Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%	Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-546	Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%	Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-546	Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%	Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-546	Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%	Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%	Alembic Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65505	ORIG	2020-12-07