Application 208552

Type: NDA
Sponsor: EPI HLTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RHOFADE	OXYMETAZOLINE HYDROCHLORIDE	CREAM;TOPICAL	1%	Yes	Yes

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
N208552-001	RHOFADE	OXYMETAZOLINE HYDROCHLORIDE	1%	CREAM / TOPICAL	AB	RLD, RS	2017-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N208552-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208552-001	7812049	2028-05-02	U-1959		2017-02-09
N208552-001	8883838	2031-12-01		Drug product	2017-02-09
N208552-001	10335391	2035-06-11	U-2567		2019-07-08
N208552-001	10751325	2035-06-11	U-2921		2020-08-26
N208552-001	11517560	2035-06-11	U-3494		2022-12-29
N208552-001	12350255	2035-06-11	U-3494		2025-07-17
N208552-001	9974773	2035-06-11	U-2306		2018-05-22

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 2 of 2 · 43 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
2022-09-29 23:25 UTC	2022-09	N208552-001	RHOFADE	1%	CREAM / TOPICAL		RLD, RS	2017-01-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208552-001	RHOFADE	1%	CREAM / TOPICAL		RLD, RS	2017-01-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208552-001	RHOFADE	1%	CREAM / TOPICAL	AB	RLD, RS	2017-01-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N208552-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208552-001	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208552-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 313 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	N208552-001	7812049	2028-05-02	U-1959		2017-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208552-001	8883838	2031-12-01		Drug product	2017-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208552-001	10335391	2035-06-11	U-2567		2019-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208552-001	10751325	2035-06-11	U-2921		2020-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208552-001	11517560	2035-06-11	U-3494		2022-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208552-001	12350255	2035-06-11	U-3494		2025-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208552-001	9974773	2035-06-11	U-2306		2018-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208552-001	7812049	2028-05-02	U-1959		2017-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208552-001	8883838	2031-12-01		Drug product	2017-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208552-001	10335391	2035-06-11	U-2567		2019-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208552-001	10751325	2035-06-11	U-2921		2020-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208552-001	11517560	2035-06-11	U-3494		2022-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208552-001	12350255	2035-06-11	U-3494		2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208552-001	9974773	2035-06-11	U-2306		2018-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208552-001	7812049	2028-05-02	U-1959		2017-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208552-001	8883838	2031-12-01		Drug product	2017-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208552-001	10335391	2035-06-11	U-2567		2019-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208552-001	10751325	2035-06-11	U-2921		2020-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208552-001	11517560	2035-06-11	U-3494		2022-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208552-001	12350255	2035-06-11	U-3494		2025-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208552-001	9974773	2035-06-11	U-2306		2018-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208552-001	7812049	2028-05-02	U-1959		2017-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208552-001	8883838	2031-12-01		Drug product	2017-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208552-001	10335391	2035-06-11	U-2567		2019-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208552-001	10751325	2035-06-11	U-2921		2020-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208552-001	11517560	2035-06-11	U-3494		2022-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208552-001	12350255	2035-06-11	U-3494		2025-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208552-001	9974773	2035-06-11	U-2306		2018-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208552-001	7812049	2028-05-02	U-1959		2017-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208552-001	8883838	2031-12-01		Drug product	2017-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208552-001	10335391	2035-06-11	U-2567		2019-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208552-001	10751325	2035-06-11	U-2921		2020-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208552-001	11517560	2035-06-11	U-3494		2022-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208552-001	12350255	2035-06-11	U-3494		2025-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208552-001	9974773	2035-06-11	U-2306		2018-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208552-001	7812049	2028-05-02	U-1959		2017-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208552-001	8883838	2031-12-01		Drug product	2017-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208552-001	10335391	2035-06-11	U-2567		2019-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208552-001	10751325	2035-06-11	U-2921		2020-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208552-001	11517560	2035-06-11	U-3494		2022-12-29	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208552-001	NP	2020-01-18	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N208552-001	NP	2020-01-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208552-001	NP	2020-01-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208552-001	NP	2020-01-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208552-001	NP	2020-01-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208552-001	NP	2020-01-18	`ea99ee380514…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rhofade	OXYMETAZOLINE HYDROCHLORIDE	Mayne Pharma	34298db6-647d-480d-88a8-dc53258a5164	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208552 application number: NDA208552
Rhofade	OXYMETAZOLINE HYDROCHLORIDE	Mayne Pharma	f7dbf12e-a802-4261-bae2-c20977698933	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208552 application number: NDA208552
Rhofade	OXYMETAZOLINE HYDROCHLORIDE	EPI Health, LLC	e82b5788-a855-4165-a81f-7f15cb874612	2023-05-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208552 application number: NDA208552 ndc (product): 71403-003

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-5300	RHOFADE	Oxymetazoline Hydrochloride	Allergan, Inc.	NDA	Current
0023-5300	RHOFADE	Oxymetazoline Hydrochloride	Allergan, Inc.	NDA	Current
0023-5300	RHOFADE	Oxymetazoline Hydrochloride	Allergan, Inc.	NDA	Current
71180-003	Rhofade	oxymetazoline Hydrochloride	Aclaris Therapeutics, Inc.	NDA	Current
71180-003	Rhofade	oxymetazoline Hydrochloride	Aclaris Therapeutics, Inc.	NDA	Current
71180-003	Rhofade	oxymetazoline Hydrochloride	Aclaris Therapeutics, Inc.	NDA	Current
71403-003	Rhofade	OXYMETAZOLINE HYDROCHLORIDE	EPI Health, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56103	ORIG	2018-10-26
46908	ORIG	2017-01-19
46916	ORIG	2017-01-18