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001	LONITEN	MINOXIDIL	TABLET;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	LONITEN	MINOXIDIL	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N018154-001	LONITEN	MINOXIDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N018154-003	LONITEN	MINOXIDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982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N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`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N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`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N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`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 8 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ERWCNMIE 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3caf4291-15b5-cdba-e063-6394a90a1a0e	2025-08-18	Warnings	Name fallback generic name: MINOXIDIL
minoxidil	MINOXIDIL	Publix Super Markets Inc	d0ff44ef-d59c-43c9-a381-448fef2cfe22	2025-08-12	Warnings	Name fallback generic name: MINOXIDIL
EZBIORT 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3c266bb4-baf3-9f79-e063-6294a90ac7a2	2025-08-12	Warnings	Name fallback generic name: MINOXIDIL
TAGOQHA 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3c267a04-d4fc-51b6-e063-6294a90a00a1	2025-08-12	Warnings	Name fallback generic name: MINOXIDIL
minoxidil	MINOXIDIL	Publix Super Markets Inc	57699890-6fef-4bd8-b690-161458131cd7	2025-08-12	Warnings	Name fallback generic name: MINOXIDIL
Trzsfr 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3b98c04d-1ff6-842e-e063-6294a90a6801	2025-08-05	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil (for Women)	MINOXIDIL	Virtue Labs, LLC	85a9d343-1135-4296-96b5-fabab6b834f9	2025-07-17	Warnings	Name fallback generic name: MINOXIDIL
hair regrowth treatment	MINOXIDIL	Walgreen Company	fb2a8bfe-7eae-4a78-a610-58c9e80adf72	2025-07-17	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil and 5% Rosemary for Hair Care	MINOXIDIL	TIKNOW LLC	1bb386d2-70c6-c487-e063-6294a90a19da	2025-07-07	Warnings	Name fallback generic name: MINOXIDIL
CYPKEB 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	371eb74f-b945-d1a8-e063-6394a90a8237	2025-06-09	Warnings	Name fallback generic name: MINOXIDIL
OCVWJKD 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	36e1cb29-cc4a-06cb-e063-6294a90a448a	2025-06-06	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Actavis Pharma, Inc.	ab30461c-f8c8-409d-9e24-d58ed8a34873	2025-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Sidinox 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	36a78022-f7ad-c6a3-e063-6294a90a0078	2025-06-03	Warnings	Name fallback generic name: MINOXIDIL
hims hair regrowth treatment	MINOXIDIL	Hims Inc	f7d7bb41-acf3-4738-b466-2ed4204b068d	2025-06-02	Warnings	Name fallback generic name: MINOXIDIL
BLIYEOGZ 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	365706a2-f822-640e-e063-6294a90a35b1	2025-05-30	Warnings	Name fallback generic name: MINOXIDIL
AMRWRIR 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3608b948-e8f3-232a-e063-6294a90a1981	2025-05-26	Warnings	Name fallback generic name: MINOXIDIL
Hair Regrowth Treatment	MINOXIDIL	CVS Pharmacy	7041e548-e3ff-4623-8c35-783c64d5f04c	2025-05-22	Warnings	Name fallback generic name: MINOXIDIL
members mark hair regrowth treatment	MINOXIDIL	Sam's West Inc	b3377092-b00d-4ab0-b62e-acd108dc330c	2025-05-22	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Walgreens	b55198cb-40d8-432b-bdd5-2ecefa35d320	2025-05-21	Warnings	Name fallback generic name: MINOXIDIL
minoxidil	MINOXIDIL	THIRTY MADISON INC	9a8528df-3cd3-4c85-b7e9-0a0e761d6cbd	2025-05-20	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