Application 216675

Type: NDA
Sponsor: BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MIEBO	PERFLUOROHEXYLOCTANE	SOLUTION/DROPS;OPHTHALMIC	1.338GM/ML	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
N216675-001	MIEBO	PERFLUOROHEXYLOCTANE	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2023-05-18

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216675-001	10058615	2033-09-12	U-1900		2023-06-08
N216675-001	10369117	2033-09-12	U-1900		2023-06-08
N216675-001	10449164	2033-09-12	U-1900		2023-06-08
N216675-001	10576154	2035-10-01	U-1900		2023-06-08
N216675-001	11357738	2036-09-29		Drug product	2023-06-08
N216675-001	10507132	2037-06-21	U-1900		2023-06-08

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216675-001	NCE	2028-05-18

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216675-001	MIEBO	1.338GM/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-05-18	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 126 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	N216675-001	10058615	2033-09-12	U-1900		2023-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216675-001	10369117	2033-09-12	U-1900		2023-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216675-001	10449164	2033-09-12	U-1900		2023-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216675-001	10576154	2035-10-01	U-1900		2023-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216675-001	11357738	2036-09-29		Drug product	2023-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216675-001	10507132	2037-06-21	U-1900		2023-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216675-001	10058615	2033-09-12	U-1900		2023-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216675-001	10369117	2033-09-12	U-1900		2023-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216675-001	10449164	2033-09-12	U-1900		2023-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216675-001	10576154	2033-09-12	U-1900		2023-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216675-001	11357738	2036-09-29		Drug product	2023-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216675-001	10507132	2037-06-21	U-1900		2023-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216675-001	10058615	2033-09-12	U-1900		2023-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216675-001	10369117	2033-09-12	U-1900		2023-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216675-001	10449164	2033-09-12	U-1900		2023-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216675-001	10576154	2033-09-12	U-1900		2023-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216675-001	11357738	2036-09-29		Drug product	2023-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216675-001	10507132	2037-06-21	U-1900		2023-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216675-001	10058615	2033-09-12	U-1900		2023-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216675-001	10369117	2033-09-12	U-1900		2023-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216675-001	10449164	2033-09-12	U-1900		2023-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216675-001	10576154	2033-09-12	U-1900		2023-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216675-001	11357738	2036-09-29		Drug product	2023-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216675-001	10507132	2037-06-21	U-1900		2023-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216675-001	10058615	2033-09-12	U-1900		2023-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216675-001	10369117	2033-09-12	U-1900		2023-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216675-001	10449164	2033-09-12	U-1900		2023-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216675-001	10576154	2033-09-12	U-1900		2023-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216675-001	11357738	2036-09-29		Drug product	2023-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216675-001	10507132	2037-06-21	U-1900		2023-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216675-001	10058615	2033-09-12	U-1900		2023-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216675-001	10369117	2033-09-12	U-1900		2023-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216675-001	10449164	2033-09-12	U-1900		2023-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216675-001	10576154	2033-09-12	U-1900		2023-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216675-001	11357738	2036-09-29		Drug product	2023-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216675-001	10507132	2037-06-21	U-1900		2023-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216675-001	10058615	2033-09-12	U-1900		2023-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216675-001	10369117	2033-09-12	U-1900		2023-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216675-001	10449164	2033-09-12	U-1900		2023-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216675-001	10576154	2033-09-12	U-1900		2023-06-08	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216675-001	NCE	2028-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216675-001	NCE	2028-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216675-001	NCE	2028-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216675-001	NCE	2028-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216675-001	NCE	2028-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216675-001	NCE	2028-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216675-001	NCE	2028-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216675-001	NCE	2028-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216675-001	NCE	2028-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216675-001	NCE	2028-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216675-001	NCE	2028-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216675-001	NCE	2028-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216675-001	NCE	2028-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216675-001	NCE	2028-05-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216675-001	NCE	2028-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216675-001	NCE	2028-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216675-001	NCE	2028-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216675-001	NCE	2028-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216675-001	NCE	2028-05-18	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216675-001	NCE	2028-05-18	`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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MIEBO	PERFLUOROHEXYLOCTANE	Bausch & Lomb Incorporated	6b283c02-7df4-4c00-951b-555cddffe77c	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216675 application number: NDA216675

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83878	SUPPL	2025-10-23
83868	SUPPL	2025-10-22
74548	ORIG	2023-06-20
74332	ORIG	2023-05-22
74323	ORIG	2023-05-19