Application 020583

Type: NDA
Sponsor: BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOTEMAX	LOTEPREDNOL ETABONATE	SUSPENSION/DROPS;OPHTHALMIC	0.5%	Yes	Yes

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
N020583-001	LOTEMAX	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020583-001	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.

Product history page 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020583-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020583-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020583-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020583-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020583-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020583-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020583-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020583-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020583-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020583-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020583-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020583-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020583-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020583-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020583-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020583-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020583-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020583-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020583-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020583-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020583-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020583-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020583-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020583-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020583-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020583-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020583-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020583-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020583-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020583-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020583-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020583-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020583-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020583-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020583-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020583-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020583-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020583-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020583-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020583-001	AB	1	`cb3db0bc1861…`

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
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Bausch & Lomb Americas Inc.	f09b1206-97c7-4f21-bda8-94f55128c5cb	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020583 application number: NDA020583
LOTEMAX	LOTEPREDNOL ETABONATE	Bausch & Lomb Incorporated	f37d74ac-5f9c-40a8-b43b-35148fc66bbe	2023-04-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020583 application number: NDA020583 ndc (product): 24208-299

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
24208-299	LOTEMAX	loteprednol etabonate	Bausch & Lomb Incorporated	NDA	Current
24208-299	LOTEMAX	loteprednol etabonate	Bausch & Lomb Incorporated	NDA	Current
24208-299	LOTEMAX	loteprednol etabonate	Bausch & Lomb Incorporated	NDA	Current
24208-299	LOTEMAX	loteprednol etabonate	Bausch & Lomb Incorporated	NDA	Current
68682-299	Loteprednol Etabonate	loteprednol etabonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-299	Loteprednol Etabonate	loteprednol etabonate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
20736	SUPPL	2015-11-18
20735	SUPPL	2015-11-18
41446	ORIG	2002-04-09
34880	ORIG	1998-03-09
25229	ORIG	1998-03-09