Application 208219

Type: NDA
Sponsor: BAUSCH AND LOMB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOTEMAX SM	LOTEPREDNOL ETABONATE	GEL;OPHTHALMIC	0.38%	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
N208219-001	LOTEMAX SM	LOTEPREDNOL ETABONATE	0.38%	GEL / OPHTHALMIC	AB	RLD, RS	2019-02-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208219-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12
N208219-001	12589069	2036-01-26	U-2764	Drug product	2026-04-30
N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31

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	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC	AB	RLD, RS	2019-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC	AB	RLD, RS	2019-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC	AB	RLD, RS	2019-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208219-001	LOTEMAX SM	0.38%	GEL / OPHTHALMIC		RLD, RS	2019-02-22	`cb3db0bc1861…`

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	N208219-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208219-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208219-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208219-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 61 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208219-001	10596107	2036-12-23	U-2764	Drug product	2020-03-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208219-001	11534395	2036-01-26	U-2764	Drug product	2023-01-12	`1c564ffb4f44…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208219-001	NS	2022-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208219-001	NS	2022-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208219-001	NS	2022-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208219-001	NS	2022-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208219-001	NS	2022-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208219-001	NS	2022-02-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208219-001	NS	2022-02-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208219-001	NS	2022-02-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208219-001	NS	2022-02-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208219-001	NS	2022-02-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208219-001	NS	2022-02-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208219-001	NS	2022-02-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208219-001	NS	2022-02-22	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N208219-001	NS	2022-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208219-001	NS	2022-02-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208219-001	NS	2022-02-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208219-001	NS	2022-02-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208219-001	NS	2022-02-22	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lotemax SM	LOTEPREDNOL ETABONATE	Bausch & Lomb Incorporated	6f9477b5-699f-4d3b-b9a6-0cc238266237	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208219 application number: NDA208219 ndc (product): 24208-507

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24208-507	Lotemax SM	loteprednol etabonate	Bausch & Lomb Incorporated	NDA	Current
24208-507	Lotemax SM	loteprednol etabonate	Bausch & Lomb Incorporated	NDA	Current
24208-507	Lotemax SM	loteprednol etabonate	Bausch & Lomb Incorporated	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60216	ORIG	2019-10-03
57904	ORIG	2019-03-05
57873	ORIG	2019-03-01