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 3 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	100b48e9-0884-4112-b9aa-cb6f07c28756	2025-07-03	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	dddad9bc-a0a3-41bf-81e5-65d9903b14c6	2025-07-03	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	fb4deae8-23f0-42dd-ac2e-b69ab39a6c4d	2025-07-03	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a0f88292-680b-4d50-ae6e-0a7bccc3a9c6	2025-07-03	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Chartwell RX, LLC	43fbe7ff-4b67-474d-bf27-e5710d8d10ac	2025-06-17	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Lifesciences Limited	8bf9cf23-8ffc-401f-981d-4878d694a468	2025-06-05	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Pharmaceuticals (USA) Inc.	85f082a5-bba1-4441-ba28-4b8ec9a537f2	2025-06-05	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Actavis Pharma, Inc.	a5fc4d50-50b2-46e0-b722-4c6b2ec47d06	2025-06-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	ec93ad27-aff5-cbc7-e053-2a95a90adc7e	2025-05-07	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	25acb785-6838-4e62-9e86-ddc30b2b759a	2025-04-26	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Aurobindo Pharma Limited	e7b88a48-12b3-461d-b356-0d7ae4e8fd44	2025-04-11	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Aurobindo Pharma Limited	9013ca48-15f2-43cd-a51d-91cf65c72a7c	2025-04-08	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	d00d9bc4-c764-4ec1-beb0-44668637bcfb	2025-01-28	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1c363cbb-099b-7c73-e063-6394a90ae13f	2025-01-02	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Aurobindo Pharma Limited	799a9871-3249-471e-b88d-5d8f7d4b96ad	2025-01-01	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f901a1ba-1716-8795-e053-6294a90a4e77	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a6224eeb-25be-4f1d-889f-809aaf338c8c	2024-10-07	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Lifesciences Limited	26ee99af-f44b-4076-a08c-0a0dedc9edfe	2024-10-03		Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	6f154720-706e-4177-8167-1bc893303f1b	2024-09-04	Warnings, Adverse reactions	Name fallback generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	abaacdeb-2433-261a-e053-2995a90ae34e	2024-07-17	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