Application 018154

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LONITEN	MINOXIDIL	TABLET;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	LONITEN	MINOXIDIL	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018154-001	LONITEN	MINOXIDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N018154-003	LONITEN	MINOXIDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018154-001	LONITEN	2.5MG	TABLET / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018154-003	LONITEN	10MG	TABLET / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018154-001	LONITEN	2.5MG	TABLET / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018154-003	LONITEN	10MG	TABLET / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`

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 10 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
kirkland signature minoxidil	MINOXIDIL	Costco Wholesale Company	ec4b79fd-f68b-4f8d-a173-983835bc82eb	2025-02-04	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil Extra Strength for Men	MINOXIDIL	Roman Health Ventures Inc.	03738dd6-a42c-0986-e063-6294a90a1cc0	2025-01-30	Warnings	Name fallback generic name: MINOXIDIL
SOLUCION CAPILAR CRECEPELO	MINOXIDIL	BOE Dominicana SRL	3d493e10-9cd9-6e2b-e063-6294a90a6d6c	2025-01-28	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Walgreens	a08edb99-3e45-4d3c-a0f8-c74bd291057a	2025-01-28	Warnings	Name fallback generic name: MINOXIDIL
HAIR BEARDGROWTH FOAM	MINOXIDIL	Shenzhen Xuemin E-commerce Co., Ltd.	2bcf1d90-8936-117a-e063-6294a90a2468	2025-01-16	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Serum	MINOXIDIL	Shenzhen Shangmei Tiantianbaodan E-commerce Co., Ltd	2bba416c-b5ec-53fa-e063-6294a90a5d9e	2025-01-15	Warnings	Name fallback generic name: MINOXIDIL
Stafenit Hair Regrowth Treatment Topical Minoxidil	MINOXIDIL	Cozesmo	cd74cc10-6df4-47bf-885e-333244db6d82	2025-01-09	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil Extra Strength for Men	MINOXIDIL	Roman Health Ventures Inc.	a568aba1-1016-4380-e053-2a95a90a396d	2025-01-08	Warnings	Name fallback generic name: MINOXIDIL
Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented	MINOXIDIL	SANTO REMEDIO LLC	2a2d814f-d716-6e60-e063-6294a90aeb97	2024-12-26	Warnings	Name fallback generic name: MINOXIDIL
Santo Remedio Womens Hair Regrowth Treatment Minoxidil Unscented	MINOXIDIL	SANTO REMEDIO LLC	cfc7adf1-627b-41e1-b51a-cdcd8a14e796	2024-12-18	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil (for Men)	MINOXIDIL	RESTORATION HOLDINGS, LLC	e18223ad-642e-81a5-e053-2a95a90a0752	2024-12-11	Warnings	Name fallback generic name: MINOXIDIL
The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System	MINOXIDIL	Invest Strong, LLC	2e19bf51-1769-4bc1-9232-9aa4b8df5847	2024-12-05	Warnings	Name fallback generic name: MINOXIDIL
Tomum Hair Growth Treatment For Men Minoxidil Unscented	MINOXIDIL	BELLEKA INC	4c0582a3-f2be-4e53-a174-12269f7ddad0	2024-12-04	Warnings	Name fallback generic name: MINOXIDIL
Womens Rogaine Unscented	MINOXIDIL	Kenvue Brands LLC	4d328537-b7f5-43cc-9837-c5a0c6c390f8	2024-11-13	Warnings	Name fallback generic name: MINOXIDIL
Mens rogaine Minoxidil Unscented Formula	MINOXIDIL	Kenvue Brands LLC	1b5e2860-6855-4a65-8bbc-e064172a1adf	2024-11-11	Warnings	Name fallback generic name: MINOXIDIL
Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength	MINOXIDIL	ESALON.COM, LLC	69b01eab-df9f-4ae8-87e4-add18883874b	2024-11-05	Warnings	Name fallback generic name: MINOXIDIL
eSalon Hair Regrowth Treatment Womens Minoxidil	MINOXIDIL	ESALON.COM, LLC	c3951cc3-83c1-4d9d-8fbe-db6f1fb3986c	2024-11-05	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	P & L Development, LLC	59e7cdae-6595-4aa2-8fe0-7a8bcf300912	2024-11-05	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	P & L Development, LLC	73dc7e7f-92c2-4ab2-a260-ceb198e591cf	2024-11-05	Warnings	Name fallback generic name: MINOXIDIL
Elevate Hair Regrowth Treatment 5	MINOXIDIL	VAPOR PRO SHOPPE, LLC	0d5e4258-a58d-4378-9be8-631114588cdb	2024-10-31	Warnings	Name fallback generic name: MINOXIDIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
14934	SUPPL	2015-01-15
11173	SUPPL	2015-01-14
861	SUPPL	2002-07-09