Application 201922

Type: NDA
Sponsor: JOURNEY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XIMINO	MINOCYCLINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 45MG BASE	No	No
002	XIMINO	MINOCYCLINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 67.5MG BASE	No	No
003	XIMINO	MINOCYCLINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 90MG BASE	No	No
004	XIMINO	MINOCYCLINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 112.5MG BASE	No	No
005	XIMINO	MINOCYCLINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 135MG BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N201922-001	XIMINO	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11
N201922-002	XIMINO	MINOCYCLINE HYDROCHLORIDE	EQ 67.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11
N201922-003	XIMINO	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11
N201922-004	XIMINO	MINOCYCLINE HYDROCHLORIDE	EQ 112.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11
N201922-005	XIMINO	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201922-001	7919483	2027-03-07	U-124		2013-04-17
N201922-001	7541347	2027-04-02	U-917		2013-04-17
N201922-001	7544373	2027-04-02		Drug product	2013-04-17
N201922-003	7919483	2027-03-07	U-124
N201922-003	7541347	2027-04-02	U-917
N201922-003	7544373	2027-04-02		Drug product
N201922-005	7919483	2027-03-07	U-124
N201922-005	7541347	2027-04-02	U-917
N201922-005	7544373	2027-04-02		Drug product

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 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N201922-001	XIMINO	EQ 45MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201922-002	XIMINO	EQ 67.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201922-003	XIMINO	EQ 90MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201922-004	XIMINO	EQ 112.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201922-005	XIMINO	EQ 135MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201922-001	XIMINO	EQ 45MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201922-002	XIMINO	EQ 67.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201922-003	XIMINO	EQ 90MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201922-004	XIMINO	EQ 112.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201922-005	XIMINO	EQ 135MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201922-001	XIMINO	EQ 45MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201922-002	XIMINO	EQ 67.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201922-003	XIMINO	EQ 90MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201922-004	XIMINO	EQ 112.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201922-005	XIMINO	EQ 135MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-001	XIMINO	EQ 45MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-002	XIMINO	EQ 67.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-003	XIMINO	EQ 90MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-004	XIMINO	EQ 112.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-005	XIMINO	EQ 135MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201922-001	XIMINO	EQ 45MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201922-002	XIMINO	EQ 67.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201922-003	XIMINO	EQ 90MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201922-004	XIMINO	EQ 112.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201922-005	XIMINO	EQ 135MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201922-001	XIMINO	EQ 45MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201922-002	XIMINO	EQ 67.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201922-003	XIMINO	EQ 90MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201922-004	XIMINO	EQ 112.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201922-005	XIMINO	EQ 135MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201922-001	XIMINO	EQ 45MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201922-002	XIMINO	EQ 67.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201922-003	XIMINO	EQ 90MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201922-004	XIMINO	EQ 112.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201922-005	XIMINO	EQ 135MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201922-001	XIMINO	EQ 45MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201922-002	XIMINO	EQ 67.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201922-003	XIMINO	EQ 90MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201922-004	XIMINO	EQ 112.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201922-005	XIMINO	EQ 135MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-11	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 19 · 738 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	N201922-001	7919483	2027-03-07	U-124		2013-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201922-001	7541347	2027-04-02	U-917		2013-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201922-001	7544373	2027-04-02		Drug product	2013-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201922-003	7919483	2027-03-07	U-124			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201922-003	7541347	2027-04-02	U-917			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201922-003	7544373	2027-04-02		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201922-005	7919483	2027-03-07	U-124			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201922-005	7541347	2027-04-02	U-917			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201922-005	7544373	2027-04-02		Drug product		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201922-001	7919483	2027-03-07	U-124		2013-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201922-001	7541347	2027-04-02	U-917		2013-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201922-001	7544373	2027-04-02		Drug product	2013-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201922-003	7919483	2027-03-07	U-124			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201922-003	7541347	2027-04-02	U-917			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201922-003	7544373	2027-04-02		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201922-005	7919483	2027-03-07	U-124			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201922-005	7541347	2027-04-02	U-917			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201922-005	7544373	2027-04-02		Drug product		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201922-001	7919483	2027-03-07	U-124		2013-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201922-001	7541347	2027-04-02	U-917		2013-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201922-001	7544373	2027-04-02		Drug product	2013-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201922-003	7919483	2027-03-07	U-124			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201922-003	7541347	2027-04-02	U-917			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201922-003	7544373	2027-04-02		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201922-005	7919483	2027-03-07	U-124			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201922-005	7541347	2027-04-02	U-917			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201922-005	7544373	2027-04-02		Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-001	7790705	2025-06-24	U-124		2013-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-001	8252776	2025-06-24	U-124		2013-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-001	8268804	2025-06-24	U-124		2013-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-001	7919483	2027-03-07	U-124		2013-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-001	7541347	2027-04-02	U-917		2013-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-001	7544373	2027-04-02		Drug product	2013-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-003	7790705	2025-06-24	U-124			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-003	8252776	2025-06-24	U-124			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-003	8268804	2025-06-24	U-124			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-003	7919483	2027-03-07	U-124			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-003	7541347	2027-04-02	U-917			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-003	7544373	2027-04-02		Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201922-005	7790705	2025-06-24	U-124			`31067a03dcf5…`

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 4 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arestin	MINOCYCLINE HYDROCHLORIDE	OraPharma, Inc.	8515df41-1936-4f3b-86ba-d2bb2a8441fb	2024-05-31	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	192327c5-d2bc-1bd1-e063-6394a90a110b	2024-05-23	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	3b1e1cf1-ebd2-4aba-a219-9f9939fdb03b	2023-10-30	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	A-S Medication Solutions	1229c84c-5627-4992-bb8a-7874b215c543	2023-09-17	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	4f904969-5af3-461e-b557-d03a1e5c7292	2023-05-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	d5fcba91-6aa6-4072-aea5-fb8da65d9aac	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	49e65b60-ffc9-4ccd-9aec-29a462358d27	2022-05-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Strides Pharma Science Limited	d6e136ba-c9b1-4846-ae2a-98a29cb4504d	2022-03-31	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	e6b04358-0f4c-4b21-a7f3-320d1e7bc0b8	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Proficient Rx LP	d67e4b17-7d44-4d72-9150-420d98cc6db3	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a84c29a9-21a8-4965-b5a5-37b28e4af5a0	2019-06-13	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10631-330	Ximino	minocycline hydrochloride	Sun Pharmaceutical Industries, Inc	NDA	Current
10631-331	Ximino	minocycline hydrochloride	Sun Pharmaceutical Industries, Inc	NDA	Current
10631-332	Ximino	minocycline hydrochloride	Sun Pharmaceutical Industries, Inc	NDA	Current
69489-121	Ximino	minocycline hydrochloride	Journey Medical Corporation	NDA	Current
69489-122	Ximino	minocycline hydrochloride	Journey Medical Corporation	NDA	Current
69489-123	Ximino	minocycline hydrochloride	Journey Medical Corporation	NDA	Current
72143-221	Minocycline Hydrochloride	minocycline hydrochloride	JG Pharma, Inc.	NDA	Current
72143-221	Minocycline Hydrochloride	minocycline hydrochloride	JG Pharma, Inc.	NDA	Current
72143-222	Minocycline Hydrochloride	minocycline hydrochloride	JG Pharma, Inc.	NDA	Current
72143-222	Minocycline Hydrochloride	minocycline hydrochloride	JG Pharma, Inc.	NDA	Current
72143-223	Minocycline Hydrochloride	minocycline hydrochloride	JG Pharma, Inc.	NDA	Current
72143-223	Minocycline Hydrochloride	minocycline hydrochloride	JG Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84945	SUPPL	2026-02-05
84881	SUPPL	2026-01-30
40092	SUPPL	2015-08-14
24404	ORIG	2013-08-13
22864	ORIG	2013-08-13
32147	ORIG	2012-07-13
19042	ORIG	2012-07-13