Application 213690

Type: NDA
Sponsor: FOAMIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZILXI	MINOCYCLINE	FOAM; TOPICAL	1.5%	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N213690-001	ZILXI	MINOCYCLINE HYDROCHLORIDE	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL		RLD, RS	2020-05-28

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213690-001	10213512	2030-10-01	U-1631	Drug product	2020-06-22
N213690-001	10265404	2030-10-01		Drug product	2020-06-22
N213690-001	10322186	2030-10-01	U-1631		2020-06-22
N213690-001	10946101	2030-10-01	U-1631		2021-03-22
N213690-001	12138311	2030-10-01	U-1631		2024-12-11
N213690-001	12661407	2030-10-01	U-1631		2026-07-14
N213690-001	8865139	2030-10-01	U-1631	Drug product	2020-06-22
N213690-001	8945516	2030-10-01		Drug product	2020-06-22
N213690-001	8992896	2030-10-01	U-1631	Drug product	2020-06-22
N213690-001	9675700	2030-10-01	U-1631	Drug product	2020-06-22

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213690-001	ZILXI	EQ 1.5% BASE	AEROSOL, FOAM / TOPICAL	RLD, RS	2020-05-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 311 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213690-001	10213512	2030-10-01	U-1631	Drug product	2020-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213690-001	10265404	2030-10-01		Drug product	2020-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213690-001	10322186	2030-10-01	U-1631		2020-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213690-001	10946101	2030-10-01	U-1631		2021-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213690-001	12138311	2030-10-01	U-1631		2024-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213690-001	12661407	2030-10-01	U-1631		2026-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213690-001	8865139	2030-10-01	U-1631	Drug product	2020-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213690-001	8945516	2030-10-01		Drug product	2020-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213690-001	8992896	2030-10-01	U-1631	Drug product	2020-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213690-001	9675700	2030-10-01	U-1631	Drug product	2020-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213690-001	10213512	2030-10-01	U-1631	Drug product	2020-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213690-001	10265404	2030-10-01		Drug product	2020-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213690-001	10322186	2030-10-01	U-1631		2020-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213690-001	10946101	2030-10-01	U-1631		2021-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213690-001	12138311	2030-10-01	U-1631		2024-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213690-001	8865139	2030-10-01	U-1631	Drug product	2020-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213690-001	8945516	2030-10-01		Drug product	2020-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213690-001	8992896	2030-10-01	U-1631	Drug product	2020-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213690-001	9675700	2030-10-01	U-1631	Drug product	2020-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213690-001	10213512	2030-10-01	U-1631	Drug product	2020-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213690-001	10265404	2030-10-01		Drug product	2020-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213690-001	10322186	2030-10-01	U-1631		2020-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213690-001	10946101	2030-10-01	U-1631		2021-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213690-001	12138311	2030-10-01	U-1631		2024-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213690-001	8865139	2030-10-01	U-1631	Drug product	2020-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213690-001	8945516	2030-10-01		Drug product	2020-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213690-001	8992896	2030-10-01	U-1631	Drug product	2020-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213690-001	9675700	2030-10-01	U-1631	Drug product	2020-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213690-001	10213512	2030-10-01	U-1631	Drug product	2020-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213690-001	10265404	2030-10-01		Drug product	2020-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213690-001	10322186	2030-10-01	U-1631		2020-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213690-001	10946101	2030-10-01	U-1631		2021-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213690-001	12138311	2030-10-01	U-1631		2024-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213690-001	8865139	2030-10-01	U-1631	Drug product	2020-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213690-001	8945516	2030-10-01		Drug product	2020-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213690-001	8992896	2030-10-01	U-1631	Drug product	2020-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213690-001	9675700	2030-10-01	U-1631	Drug product	2020-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213690-001	10213512	2030-10-01	U-1631	Drug product	2020-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213690-001	10265404	2030-10-01		Drug product	2020-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213690-001	10322186	2030-10-01	U-1631		2020-06-22	`fd3edfee7708…`

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
ZILXI	MINOCYCLINE	Journey Medical Corporation	cbffa96e-2446-43cf-ba5e-38c645302afd	2024-02-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213690 application number: NDA213690 ndc (product): 69489-212

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
69489-212	ZILXI	Minocycline	Journey Medical Corporation	NDA	Current
72356-103	ZILXI	Minocycline	Foamix Pharmaceuticals Inc.	NDA	Current
72356-103	ZILXI	Minocycline	VYNE Pharmaceuticals Inc.	NDA	Current
72356-103	ZILXI	Minocycline	Journey Medical Corporation	NDA	Current
72356-103	ZILXI	Minocycline	Foamix Pharmaceuticals Inc.	NDA	Current
72356-103	ZILXI	Minocycline	VYNE Pharmaceuticals Inc.	NDA	Current
72356-103	ZILXI	Minocycline	Journey Medical Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77700	SUPPL	2024-03-04
64944	ORIG	2020-10-20
63364	ORIG	2020-06-01
63338	ORIG	2020-05-29