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001	LONITEN	MINOXIDIL	TABLET;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	LONITEN	MINOXIDIL	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N018154-001	LONITEN	MINOXIDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N018154-003	LONITEN	MINOXIDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982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N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`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N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`c2088c7a36db…`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N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`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 6 of 13 · 250 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MINOXIDIL 5% (FOR MEN)	MINOXIDIL	Aurohealth LLC	e6b3b997-cde9-476d-b08c-4d1010456d8b	2026-01-22	Warnings	Name fallback generic name: MINOXIDIL
MINOXIDIL	MINOXIDIL	AvKARE	02d7399f-94cc-f718-f214-587301edd138	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
REGOXIDINE (FOR WOMEN)	MINOXIDIL	INNOVUS PHARMACEUTICALS, INC.	9c06c34d-5a09-47ed-b969-cc81f4ed61ab	2026-01-20	Warnings	Name fallback generic name: MINOXIDIL
REGOXIDINE (FOR MEN)	MINOXIDIL	INNOVUS PHARMACEUTICALS, INC.	d191b3a9-0fb7-45cc-82a1-b64a79c0c125	2026-01-20	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	NuCare Pharmaceuticals, Inc.	2e5a2976-06fb-43f9-e063-6294a90a3bf5	2026-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Hair Regen Hair Growth Treatment	MINOXIDIL	YIWUYIZHOUTRADINGCO.,LTD	15ac989a-6602-d6ec-e063-6294a90a8a48	2026-01-04	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Topical Solution	MINOXIDIL	Yiwu Pu Feather Trading Co., LTD	473c555b-de13-56d5-e063-6394a90a377f	2025-12-31	Warnings	Name fallback generic name: MINOXIDIL
Dr. Bosley Minoxidil (For Men) Hair Regrowth Treatment	MINOXIDIL	Scientific Hair Research, LLC	94da001e-4f5d-43c3-b5e9-48401203513c	2025-12-09	Warnings	Name fallback generic name: MINOXIDIL
Loesch Hair Regrowth Formula Unscented Topical Solution Extra-Strength for Men	MINOXIDIL	Loesch Laboratory Consultant, INC.	d158d3af-6850-48c0-8355-9df0637684cc	2025-12-03	Warnings	Name fallback generic name: MINOXIDIL
iBeaLee 5-in-1 5% Minoxidil Hair Regrowth Solution	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	449fd486-69e2-2894-e063-6394a90a1421	2025-11-27	Warnings	Name fallback generic name: MINOXIDIL
TNEGHC 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	4376b747-257d-433b-e063-6394a90a8df5	2025-11-13	Warnings	Name fallback generic name: MINOXIDIL
KEEPS MINOXIDIL TOPICAL	MINOXIDIL	THIRTY MADISON INC	4b8c9b60-4cc5-4604-b544-d29401fcab73	2025-11-10	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	A-S Medication Solutions	f00f3370-0313-4ce0-be7d-80db4477d9ae	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	A-S Medication Solutions	6c85c69e-b5af-4e98-aacf-f65ad15d00d7	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
5% minoxidil with biotin topical solution	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	425d9ed2-d04f-5946-e063-6294a90a7649	2025-10-30	Warnings	Name fallback generic name: MINOXIDIL
RDVHDLW 5% Minoxidil Hair Growth Foam with Biotin	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	41ba1c1a-2193-466f-e063-6294a90a18f9	2025-10-22	Warnings	Name fallback generic name: MINOXIDIL
hair regrowth treatment	MINOXIDIL	Rite Aid Corporation	00c83180-0e13-4a07-9ce8-a9cae19a79a3	2025-10-08	Warnings	Name fallback generic name: MINOXIDIL
aromatica hair leave in romero con minoxidil	MINOXIDIL	LABORATORIO MK SRL	4020b4c4-6ee8-4aec-e063-6294a90a785e	2025-10-08	Warnings	Name fallback generic name: MINOXIDIL
RegrowthX Hair Regrowth Treatment Minoxidil	MINOXIDIL	Nimex Group Inc	77f70f47-8122-481c-b5f1-17e467f2c81b	2025-10-06	Warnings	Name fallback generic name: MINOXIDIL
Happy Head Mens Extra Strength Minoxidil	MINOXIDIL	Happy Head, Inc	d3b4bc29-38c9-4180-a6d1-1ab1891897a2	2025-10-06	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