Application 215058

Type: ANDA
Sponsor: INGENUS PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIFITEGRAST	LIFITEGRAST	SOLUTION/DROPS;OPHTHALMIC	5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A215058-001	LIFITEGRAST	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC			2024-10-03

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
2026-02-19 14:30 UTC	2026-02	A215058-001	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC		2024-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215058-001	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC		2024-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215058-001	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC		2024-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215058-001	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC		2024-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215058-001	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC		2024-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215058-001	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC		2024-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215058-001	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC		2024-10-03	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215058-001	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC	AB	2024-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215058-001	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC	AB	2024-10-03	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215058-001	LIFITEGRAST	5%	SOLUTION/DROPS / OPHTHALMIC		2024-10-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215058-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215058-001	AB	1	`d06236e962d9…`

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
Xiidra	LIFITEGRAST	Novartis Pharmaceuticals Corporation	8589d376-ac10-4ddb-9c53-2e0c8d5675c4	2025-08-18	Adverse reactions	Name fallback generic name: LIFITEGRAST
Xiidra	LIFITEGRAST	Bausch & Lomb Incorporated	1a914080-a3c0-44be-b601-0ae3160e77eb	2024-11-21	Adverse reactions	Name fallback generic name: LIFITEGRAST
Lifitegrast	LIFITEGRAST	Aurobindo Pharma Limited	1d4b4b61-79da-4b6f-bb19-056d111bf400	2023-11-13	Adverse reactions	Name fallback brand name: Lifitegrast generic name: LIFITEGRAST

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73993	ORIG	2023-04-14