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001	LONITEN	MINOXIDIL	TABLET;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	LONITEN	MINOXIDIL	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N018154-001	LONITEN	MINOXIDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N018154-003	LONITEN	MINOXIDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982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N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`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N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`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N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`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 7 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
aromatica hair gota de brillo romero con minoxidil	MINOXIDIL	LABORATORIO MK SRL	4032a965-844a-64a0-e063-6394a90ad26d	2025-10-02	Warnings	Name fallback generic name: MINOXIDIL
aromatica hair acondicionador romero con minoxidil	MINOXIDIL	LABORATORIO MK SRL	401f9960-e207-f489-e063-6394a90ad79d	2025-10-01	Warnings	Name fallback generic name: MINOXIDIL
aromatica hair tratamiento romero con minoxidil	MINOXIDIL	LABORATORIO MK SRL	40204efa-7be3-efd9-e063-6394a90acb0a	2025-10-01	Warnings	Name fallback generic name: MINOXIDIL
iBeaLee 5% Minoxidil Hair Regrowth Solution	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	40001edd-d98c-4e2a-e063-6394a90a9911	2025-09-30	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Foam	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3feb9ac0-2cd1-9db2-e063-6394a90acab9	2025-09-29	Warnings	Name fallback generic name: MINOXIDIL
aromatica hair champu	MINOXIDIL	LABORATORIO MK SRL	3fb7dbd0-0eb9-cbee-e063-6294a90a63c2	2025-09-26	Warnings	Name fallback generic name: MINOXIDIL
Happy Head Womens Hair Regrowth Treatment	MINOXIDIL	Happy Head, Inc	1e447c66-a8c9-42a4-94e9-b8739543834e	2025-09-24	Warnings	Name fallback generic name: MINOXIDIL
Etaderm Mens Minoxidil Hair Regrowth Treatment Extra Strength	MINOXIDIL	NUEPHASE LLC	fb838abf-43bf-4f7d-af78-18b7145946f4	2025-09-15	Warnings	Name fallback generic name: MINOXIDIL
5% MINOXIDIL HAIR REGROWTH SERUM With Biotin	MINOXIDIL	Shenzhen Ctrip Technology Co., Ltd.	1eae27bc-1b18-ae5d-e063-6394a90a4610	2025-09-12	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Foam with Biotin	MINOXIDIL	Shenzhen Ctrip Technology Co., Ltd.	21bb47c4-47c3-df7c-e063-6394a90abe15	2025-09-12	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Topical Solution	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3e569e69-55b9-1d01-e063-6294a90a88ed	2025-09-09	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Foam with Biotin	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3e5595a6-b36e-2567-e063-6294a90a2078	2025-09-08	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Foam with Biotin	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3e56352b-21ea-ce99-e063-6294a90a8066	2025-09-08	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Proficient Rx LP	a0066eac-cb58-49ef-a480-105cb1043c2b	2025-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
hair leave in	MINOXIDIL	LABORATORIO MK SRL	3cf686b8-01b6-98b3-e063-6294a90a59cb	2025-08-29	Warnings	Name fallback generic name: MINOXIDIL
hair growth solution	MINOXIDIL	LABORATORIO MK SRL	3c3f84da-c4bc-36ac-e063-6394a90aa8d1	2025-08-29	Warnings	Name fallback generic name: MINOXIDIL
hair treatment	MINOXIDIL	LABORATORIO MK SRL	3cf60fba-8c8d-d56f-e063-6294a90a344b	2025-08-29	Warnings	Name fallback generic name: MINOXIDIL
hair acondicionador	MINOXIDIL	LABORATORIO MK SRL	3cf543f6-d61e-f6f0-e063-6394a90a347a	2025-08-29	Warnings	Name fallback generic name: MINOXIDIL
hair champu	MINOXIDIL	LABORATORIO MK SRL	3ce73d95-3199-1ca3-e063-6394a90a2207	2025-08-29	Warnings	Name fallback generic name: MINOXIDIL
HAIR GROWTH FOAM	MINOXIDIL	Shenzhen Shandian Jingling Technology Co., Ltd.	3ceecb17-b013-f957-e063-6394a90ae2ed	2025-08-22	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