Application 212520

Type: NDA
Sponsor: RVL PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	UPNEEQ	OXYMETAZOLINE HYDROCHLORIDE	SOLUTION;OPHTHALMIC	0.1%	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N212520-001	UPNEEQ	OXYMETAZOLINE HYDROCHLORIDE	0.1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2020-07-08

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
N212520-001	10912765	2031-08-26	U-2849		2021-02-10
N212520-001	8357714	2031-08-26	U-2849		2020-07-14
N212520-001	9867808	2031-08-26	U-2849		2020-07-14
N212520-001	10799481	2039-12-16	U-2849		2020-10-20
N212520-001	10814001	2039-12-16		Drug product	2020-11-02
N212520-001	10898573	2039-12-16		Drug product	2021-01-27
N212520-001	10940138	2039-12-16	U-2849		2021-03-10
N212520-001	11103482	2039-12-16		Drug product	2021-09-10
N212520-001	11311515	2039-12-16		Drug product	2022-05-03
N212520-001	11324722	2039-12-16	U-2849		2022-05-11
N212520-001	11541036	2039-12-16		Drug product	2023-01-05
N212520-001	11701343	2039-12-16	U-2849		2023-11-07
N212520-001	12605363	2039-12-16		Drug product	2026-05-07
N212520-001	12648930	2039-12-16	U-2849		2026-06-23

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
2026-09-14 22:38:34	2026-08	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212520-001	UPNEEQ	0.1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2020-07-08	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 415 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212520-001	10912765	2031-08-26	U-2849		2021-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	8357714	2031-08-26	U-2849		2020-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	9867808	2031-08-26	U-2849		2020-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	10799481	2039-12-16	U-2849		2020-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	10814001	2039-12-16		Drug product	2020-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	10898573	2039-12-16		Drug product	2021-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	10940138	2039-12-16	U-2849		2021-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	11103482	2039-12-16		Drug product	2021-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	11311515	2039-12-16		Drug product	2022-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	11324722	2039-12-16	U-2849		2022-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	11541036	2039-12-16		Drug product	2023-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	11701343	2039-12-16	U-2849		2023-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	12605363	2039-12-16		Drug product	2026-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212520-001	12648930	2039-12-16	U-2849		2026-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212520-001	10912765	2031-08-26	U-2849		2021-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	8357714	2031-08-26	U-2849		2020-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	9867808	2031-08-26	U-2849		2020-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	10799481	2039-12-16	U-2849		2020-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	10814001	2039-12-16		Drug product	2020-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	10898573	2039-12-16		Drug product	2021-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	10940138	2039-12-16	U-2849		2021-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	11103482	2039-12-16		Drug product	2021-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	11311515	2039-12-16		Drug product	2022-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	11324722	2039-12-16	U-2849		2022-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	11541036	2039-12-16		Drug product	2023-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	11701343	2039-12-16	U-2849		2023-11-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	12605363	2039-12-16		Drug product	2026-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212520-001	12648930	2039-12-16	U-2849		2026-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212520-001	10912765	2031-08-26	U-2849		2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212520-001	8357714	2031-08-26	U-2849		2020-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212520-001	9867808	2031-08-26	U-2849		2020-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212520-001	10799481	2039-12-16	U-2849		2020-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212520-001	10814001	2039-12-16		Drug product	2020-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212520-001	10898573	2039-12-16		Drug product	2021-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212520-001	10940138	2039-12-16	U-2849		2021-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212520-001	11103482	2039-12-16		Drug product	2021-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212520-001	11311515	2039-12-16		Drug product	2022-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212520-001	11324722	2039-12-16	U-2849		2022-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212520-001	11541036	2039-12-16		Drug product	2023-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212520-001	11701343	2039-12-16	U-2849		2023-11-07	`011fe1cb6892…`

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	N212520-001	NP	2023-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212520-001	NP	2023-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212520-001	NP	2023-07-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212520-001	NP	2023-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212520-001	NP	2023-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212520-001	NP	2023-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212520-001	NP	2023-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212520-001	NP	2023-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212520-001	NP	2023-07-08	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N212520-001	NP	2023-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212520-001	NP	2023-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212520-001	NP	2023-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212520-001	NP	2023-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212520-001	NP	2023-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212520-001	NP	2023-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212520-001	NP	2023-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212520-001	NP	2023-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212520-001	NP	2023-07-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212520-001	NP	2023-07-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212520-001	NP	2023-07-08	`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
UPNEEQ	OXYMETAZOLINE HYDROCHLORIDE OPHTHALMIC	RVL Pharmaceuticals, Inc.	cf6c9a1f-2367-46d2-99c3-c7d67ec6f519	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212520 application number: NDA212520 ndc (product): 73687-062

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
73687-062	UPNEEQ	Oxymetazoline hydrochloride ophthalmic	RVL Pharmaceuticals, Inc.	NDA	Current
73687-062	UPNEEQ	Oxymetazoline hydrochloride ophthalmic	RVL Pharmaceuticals, Inc.	NDA	Current
73687-062	UPNEEQ	Oxymetazoline hydrochloride ophthalmic	RVL Pharmaceuticals, Inc.	NDA	Current
73687-062	UPNEEQ	Oxymetazoline hydrochloride ophthalmic	RVL Pharmaceuticals, Inc.	NDA	Current
73687-062	UPNEEQ	Oxymetazoline hydrochloride ophthalmic	RVL Pharmaceuticals, Inc.	NDA	Current
73687-062	UPNEEQ	Oxymetazoline hydrochloride ophthalmic	RVL Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67432	SUPPL	2021-05-07
67418	SUPPL	2021-05-05
66999	ORIG	2021-04-07
64290	SUPPL	2020-08-17
64287	SUPPL	2020-08-17
63835	ORIG	2020-07-09
63829	ORIG	2020-07-09