Application 215384

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	GEL;OPHTHALMIC	0.5%	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
A215384-001	LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB		2023-08-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215384-001	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.

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	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215384-001	LOTEPREDNOL ETABONATE	0.5%	GEL / OPHTHALMIC	AB	2023-08-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215384-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215384-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215384-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215384-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215384-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215384-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215384-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215384-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215384-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215384-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215384-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215384-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215384-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215384-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215384-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215384-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215384-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215384-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215384-001	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215384-001	AB	1	`a50c72e98297…`

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 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Sun Pharmaceutical Industries, Inc.	36cfd5b8-c892-44e1-aaed-fb32d7aeca7c	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Loteprednol Etabonate generic name: LOTEPREDNOL ETABONATE
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	NorthStar RxLLC	ed9f004b-f910-4d75-b205-e96b6254946e	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: LOTEPREDNOL ETABONATE generic name: LOTEPREDNOL ETABONATE
Inveltys	LOTEPREDNOL ETABONATE	Alcon Laboratories, Inc.	bdd18e84-79b3-4c8b-a07f-eb06cf52e68c	2026-07-01	Warnings, Adverse reactions	Name fallback generic name: LOTEPREDNOL ETABONATE
Inveltys	LOTEPREDNOL ETABONATE	ALCON LABORATORIES, INC.	2ec16df8-2e5c-4e06-8d28-21df76f27d72	2026-07-01	Warnings, Adverse reactions	Name fallback generic name: LOTEPREDNOL ETABONATE
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Sentiss Pharmaceuticals LLC	4faa8cbe-2004-e8b5-e063-6394a90a3550	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: Loteprednol Etabonate generic name: LOTEPREDNOL ETABONATE
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Sentiss Pharmaceuticals LLC	f210d817-409f-4e69-b8d0-58883c0b43d3	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: Loteprednol Etabonate generic name: LOTEPREDNOL ETABONATE
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Sentiss Pharmaceuticals LLC	1fb8140b-c5a3-40eb-8429-2e570921917b	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Loteprednol Etabonate generic name: LOTEPREDNOL ETABONATE
Lotemax SM	LOTEPREDNOL ETABONATE	Bausch & Lomb Incorporated	6f9477b5-699f-4d3b-b9a6-0cc238266237	2026-03-31	Warnings, Adverse reactions	Name fallback generic name: LOTEPREDNOL ETABONATE
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Sportpharm LLC	1677e1a2-c598-4341-ab01-927f32e1b856	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Loteprednol Etabonate generic name: LOTEPREDNOL ETABONATE
loteprednol etabonate	LOTEPREDNOL ETABONATE	Lupin Pharmaceuticals, Inc.	1a506712-b032-463a-9a17-480558445808	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: loteprednol etabonate generic name: LOTEPREDNOL ETABONATE
loteprednol etabonate	LOTEPREDNOL ETABONATE	Bausch & Lomb Americas Inc.	7714824b-29ed-442a-ad2d-13ee2fc6bc42	2026-02-07	Warnings, Adverse reactions	Name fallback brand name: loteprednol etabonate generic name: LOTEPREDNOL ETABONATE
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	Amneal Pharmaceuticals NY LLC	e8b50444-fd49-427e-9c1b-f75cb1b62bb6	2025-05-21	Warnings, Adverse reactions	Name fallback brand name: LOTEPREDNOL ETABONATE generic name: LOTEPREDNOL ETABONATE
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Bausch & Lomb Americas Inc.	f09b1206-97c7-4f21-bda8-94f55128c5cb	2025-03-28	Warnings, Adverse reactions	Name fallback brand name: Loteprednol Etabonate generic name: LOTEPREDNOL ETABONATE
Eysuvis	LOTEPREDNOL ETABONATE	ALCON LABORATORIES, INC.	a2169d82-4275-4ab6-a1c3-c274080b815c	2025-03-11	Warnings, Adverse reactions	Name fallback generic name: LOTEPREDNOL ETABONATE
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Bausch & Lomb Americas Inc.	cc8638ae-0444-4a8b-bcad-fa946f607b5d	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Loteprednol Etabonate generic name: LOTEPREDNOL ETABONATE
loteprednol etabonate	LOTEPREDNOL ETABONATE	Amneal Pharmaceuticals NY LLC	3c2e7083-6ba1-4131-a23f-462b02e5c036	2024-12-11	Warnings, Adverse reactions	Name fallback brand name: loteprednol etabonate generic name: LOTEPREDNOL ETABONATE
LOTEMAX	LOTEPREDNOL ETABONATE	Bausch & Lomb Incorporated	9a666065-d467-42b8-8ecd-0ec1de9986d5	2024-10-24	Warnings, Adverse reactions	Name fallback generic name: LOTEPREDNOL ETABONATE
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	ARMAS PHARMACEUTICALS INC.	36c05fa4-6562-4af8-86ac-e79003ee65dd	2024-05-31	Warnings, Adverse reactions	Name fallback brand name: Loteprednol Etabonate generic name: LOTEPREDNOL ETABONATE
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	Padagis US LLC	55ec893d-4955-4d2c-8b5b-84f462d23e02	2024-04-01	Warnings, Adverse reactions	Name fallback brand name: LOTEPREDNOL ETABONATE generic name: LOTEPREDNOL ETABONATE
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	Padagis US LLC	63372922-4d41-4d81-8d9b-eebaf44acabf	2024-02-29	Warnings, Adverse reactions	Name fallback brand name: LOTEPREDNOL ETABONATE generic name: LOTEPREDNOL ETABONATE