Application 217064

Type: NDA
Sponsor: FAMYGEN LIFE SCI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RYZUMVI	PHENTOLAMINE MESYLATE	SOLUTION;OPHTHALMIC	EQ 0.75% BASE	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
N217064-001	RYZUMVI	PHENTOLAMINE MESYLATE	EQ 0.75% BASE	SOLUTION / OPHTHALMIC		RLD, RS	2023-09-25

Orange Book patents#

Current patent rows page 1 of 1 · 11 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217064-001	10278918	2034-01-31		Drug product	2024-02-01
N217064-001	10772829	2034-01-31		Drug product	2024-02-01
N217064-001	11090261	2034-01-31		Drug product	2024-02-01
N217064-001	11844858	2034-01-31		Drug product	2024-01-18
N217064-001	12350366	2034-01-31		Drug product	2025-07-30
N217064-001	9795560	2034-01-31		Drug product	2024-02-01
N217064-001	11400077	2039-10-25	U-3804		2024-02-01
N217064-001	12201615	2039-10-25	U-3804		2025-01-27
N217064-001	12201616	2039-10-25	U-3804		2025-01-27
N217064-001	12576066	2039-10-25	U-3804		2026-04-14
N217064-001	12576067	2039-10-25	U-3804		2026-04-14

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217064-001	NP	2026-09-25

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	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217064-001	RYZUMVI	EQ 0.75% BASE	SOLUTION / OPHTHALMIC	RLD, RS	2023-09-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 119 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	N217064-001	10278918	2034-01-31		Drug product	2024-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217064-001	10772829	2034-01-31		Drug product	2024-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217064-001	11090261	2034-01-31		Drug product	2024-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217064-001	11844858	2034-01-31		Drug product	2024-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217064-001	12350366	2034-01-31		Drug product	2025-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217064-001	9795560	2034-01-31		Drug product	2024-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217064-001	11400077	2039-10-25	U-3804		2024-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217064-001	12201616	2039-10-25	U-3804		2025-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217064-001	12201615	2039-12-25	U-3804		2025-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217064-001	10278918	2034-01-31		Drug product	2024-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217064-001	10772829	2034-01-31		Drug product	2024-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217064-001	11090261	2034-01-31		Drug product	2024-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217064-001	11844858	2034-01-31		Drug product	2024-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217064-001	12350366	2034-01-31		Drug product	2025-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217064-001	9795560	2034-01-31		Drug product	2024-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217064-001	11400077	2039-10-25	U-3804		2024-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217064-001	12201616	2039-10-25	U-3804		2025-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217064-001	12201615	2039-12-25	U-3804		2025-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217064-001	10278918	2034-01-31		Drug product	2024-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217064-001	10772829	2034-01-31		Drug product	2024-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217064-001	11090261	2034-01-31		Drug product	2024-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217064-001	11844858	2034-01-31		Drug product	2024-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217064-001	12350366	2034-01-31		Drug product	2025-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217064-001	9795560	2034-01-31		Drug product	2024-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217064-001	11400077	2039-10-25	U-3804		2024-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217064-001	12201616	2039-10-25	U-3804		2025-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217064-001	12201615	2039-12-25	U-3804		2025-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217064-001	10278918	2034-01-31		Drug product	2024-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217064-001	10772829	2034-01-31		Drug product	2024-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217064-001	11090261	2034-01-31		Drug product	2024-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217064-001	11844858	2034-01-31		Drug product	2024-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217064-001	9795560	2034-01-31		Drug product	2024-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217064-001	11400077	2039-10-25	U-3804		2024-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217064-001	12201616	2039-10-25	U-3804		2025-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217064-001	12201615	2039-12-25	U-3804		2025-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217064-001	10278918	2034-01-31		Drug product	2024-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217064-001	10772829	2034-01-31		Drug product	2024-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217064-001	11090261	2034-01-31		Drug product	2024-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217064-001	11844858	2034-01-31		Drug product	2024-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217064-001	9795560	2034-01-31		Drug product	2024-02-01	`b8a1b40f171c…`

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	N217064-001	NP	2026-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217064-001	NP	2026-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217064-001	NP	2026-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217064-001	NP	2026-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217064-001	NP	2026-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217064-001	NP	2026-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217064-001	NP	2026-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217064-001	NP	2026-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217064-001	NP	2026-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217064-001	NP	2026-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217064-001	NP	2026-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217064-001	NP	2026-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217064-001	NP	2026-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217064-001	NP	2026-09-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217064-001	NP	2026-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217064-001	NP	2026-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217064-001	NP	2026-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217064-001	NP	2026-09-25	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217064-001	NP	2026-09-25	`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
Ryzumvi	PHENTOLAMINE MESYLATE	Oyster Point Pharma, Inc.	96bb1e53-c2cc-4e60-a21a-db0269c371bf	2026-03-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217064 application number: NDA217064

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77889	ORIG	2024-03-21
76684	SUPPL	2023-11-29
76673	SUPPL	2023-11-29
75567	ORIG	2023-09-26
75564	ORIG	2023-09-26