Application 210565

Type: NDA
Sponsor: KALA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INVELTYS	LOTEPREDNOL ETABONATE	SUSPENSION/DROPS;OPHTHALMIC	1%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N210565-001	INVELTYS	LOTEPREDNOL ETABONATE	1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	2018-08-22

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210565-001	10058511	2033-05-03	U-2492	Drug product	2018-09-10
N210565-001	10646437	2033-05-03		Drug product	2020-06-11
N210565-001	10688045	2033-05-03		Drug product	2020-07-16
N210565-001	10864219	2033-05-03	U-3011		2020-12-28
N210565-001	11219597	2033-05-03	U-3278		2022-01-21
N210565-001	11219597	2033-05-03	U-3279		2022-01-21
N210565-001	11642317	2033-05-03		Drug product	2023-05-31
N210565-001	11872318	2033-05-03		Drug product	2024-02-01
N210565-001	12115246	2033-05-03	U-4025	Drug product	2024-11-08
N210565-001	9056057	2033-05-03	U-2491	Drug product	2018-09-10
N210565-001	9393213	2033-05-03		Drug product	2018-09-10
N210565-001	9532955	2033-05-03	U-2491		2018-09-10
N210565-001	9737491	2033-05-03	U-2492		2018-09-10
N210565-001	9827191	2033-05-03	U-2493	Drug product	2018-09-10

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 508 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210565-001	10058511	2033-05-03	U-2492	Drug product	2018-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	10646437	2033-05-03		Drug product	2020-06-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	10688045	2033-05-03		Drug product	2020-07-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	10864219	2033-05-03	U-3011		2020-12-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	11219597	2033-05-03	U-3278		2022-01-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	11219597	2033-05-03	U-3279		2022-01-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	11642317	2033-05-03		Drug product	2023-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	11872318	2033-05-03		Drug product	2024-02-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	12115246	2033-05-03	U-4025	Drug product	2024-11-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	9056057	2033-05-03	U-2491	Drug product	2018-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	9393213	2033-05-03		Drug product	2018-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	9532955	2033-05-03	U-2491		2018-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	9737491	2033-05-03	U-2492		2018-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	9827191	2033-05-03	U-2493	Drug product	2018-09-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210565-001	10058511	2033-05-03	U-2492	Drug product	2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	10646437	2033-05-03		Drug product	2020-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	10688045	2033-05-03		Drug product	2020-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	10864219	2033-05-03	U-3011		2020-12-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	11219597	2033-05-03	U-3278		2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	11219597	2033-05-03	U-3279		2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	11642317	2033-05-03		Drug product	2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	11872318	2033-05-03		Drug product	2024-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	12115246	2033-05-03	U-4025	Drug product	2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	9056057	2033-05-03	U-2491	Drug product	2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	9393213	2033-05-03		Drug product	2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	9532955	2033-05-03	U-2491		2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	9737491	2033-05-03	U-2492		2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	9827191	2033-05-03	U-2493	Drug product	2018-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210565-001	10058511	2033-05-03	U-2492	Drug product	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	10646437	2033-05-03		Drug product	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	10688045	2033-05-03		Drug product	2020-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	10864219	2033-05-03	U-3011		2020-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	11219597	2033-05-03	U-3278		2022-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	11219597	2033-05-03	U-3279		2022-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	11642317	2033-05-03		Drug product	2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	11872318	2033-05-03		Drug product	2024-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	12115246	2033-05-03	U-4025	Drug product	2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	9056057	2033-05-03	U-2491	Drug product	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	9393213	2033-05-03		Drug product	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	9532955	2033-05-03	U-2491		2018-09-10	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N210565-001	NP	2021-08-22	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N210565-001	NP	2021-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210565-001	NP	2021-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210565-001	NP	2021-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210565-001	NP	2021-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210565-001	NP	2021-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210565-001	NP	2021-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210565-001	NP	2021-08-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210565-001	NP	2021-08-22	`ea99ee380514…`

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 · 24 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 generic name: LOTEPREDNOL ETABONATE
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	NorthStar RxLLC	ed9f004b-f910-4d75-b205-e96b6254946e	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: LOTEPREDNOL ETABONATE
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	Padagis US LLC	63372922-4d41-4d81-8d9b-eebaf44acabf	2026-05-31	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 generic name: LOTEPREDNOL ETABONATE
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Sentiss Pharmaceuticals LLC	f210d817-409f-4e69-b8d0-58883c0b43d3	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: LOTEPREDNOL ETABONATE
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Sentiss Pharmaceuticals LLC	1fb8140b-c5a3-40eb-8429-2e570921917b	2026-04-15	Warnings, Adverse reactions	Name fallback 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 generic name: LOTEPREDNOL ETABONATE
loteprednol etabonate	LOTEPREDNOL ETABONATE	Lupin Pharmaceuticals, Inc.	1a506712-b032-463a-9a17-480558445808	2026-02-12	Warnings, Adverse reactions	Name fallback 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 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 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 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 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 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 generic name: LOTEPREDNOL ETABONATE
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	Padagis US LLC	55ec893d-4955-4d2c-8b5b-84f462d23e02	2024-04-01	Warnings, Adverse reactions	Name fallback generic name: LOTEPREDNOL ETABONATE
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	ARMAS PHARMACEUTICALS INC.	08a091a8-748f-acc4-e063-6394a90af4bc	2023-10-26	Warnings, Adverse reactions	Name fallback generic name: LOTEPREDNOL ETABONATE
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	ARMAS PHARMACEUTICALS INC.	091a068f-f9b0-b02b-e063-6294a90a95e6	2023-10-25	Warnings, Adverse reactions	Name fallback generic name: LOTEPREDNOL ETABONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71571-121	Inveltys	loteprednol etabonate	ALCON LABORATORIES, INC.	NDA	Current
71571-121	Inveltys	loteprednol etabonate	Kala Pharmaceuticals, Inc.	NDA	Current
71571-121	Inveltys	loteprednol etabonate	Kala Pharmaceuticals, Inc.	NDA	Current
71571-121	Inveltys	loteprednol etabonate	Kala Pharmaceuticals, Inc.	NDA	Current
71571-121	INVELTYS	loteprednol etabonate	Kala Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62700	SUPPL	2020-04-28
62689	SUPPL	2020-04-27
57496	ORIG	2019-02-08
55311	ORIG	2018-08-24
55271	ORIG	2018-08-23