Application 219015

Type: NDA
Sponsor: JOURNEY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EMROSI	MINOCYCLINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 40MG 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
N219015-001	EMROSI	MINOCYCLINE HYDROCHLORIDE	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL		RLD, RS	2024-11-01

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N219015-001	10905664	2039-01-07	U-4043	2024-11-25
N219015-001	11191740	2039-01-07	U-4043	2024-11-25
N219015-001	11364212	2039-01-07	U-4043	2024-11-25
N219015-001	12594252	2039-01-07	U-4043	2026-04-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219015-001	NP	2027-11-01

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	N219015-001	EMROSI	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219015-001	EMROSI	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219015-001	EMROSI	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219015-001	EMROSI	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219015-001	EMROSI	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219015-001	EMROSI	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219015-001	EMROSI	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219015-001	EMROSI	EQ 40MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2024-11-01	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219015-001	10905664	2039-01-07	U-4043	2024-11-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219015-001	11191740	2039-01-07	U-4043	2024-11-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219015-001	11364212	2039-01-07	U-4043	2024-11-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219015-001	12594252	2039-01-07	U-4043	2026-04-16	`a50c72e98297…`

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	N219015-001	NP	2027-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219015-001	NP	2027-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219015-001	NP	2027-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219015-001	NP	2027-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219015-001	NP	2027-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219015-001	NP	2027-11-01	`03ed91905a0d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219015-001	NP	2027-11-01	`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
EMROSI	MINOCYCLINE HYDROCHLORIDE EXTENDED-RELEASE	Journey Medical Corporation	0899eb25-8807-037c-f66c-141a2696b1c0	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219015 application number: NDA219015

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83647	ORIG	2025-10-06
80146	ORIG	2024-11-05
80133	ORIG	2024-11-05