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001	LONITEN	MINOXIDIL	TABLET;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	LONITEN	MINOXIDIL	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N018154-001	LONITEN	MINOXIDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N018154-003	LONITEN	MINOXIDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982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 2 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
2019-12-13 00:20 UTC	2019-12	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	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	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018154-001	LONITEN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018154-003	LONITEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`

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 13 · 250 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	FlexiGo Inc	5406743a-b688-346e-e063-6294a90a2caf	2026-09-20	Warnings	Name fallback generic name: MINOXIDIL
HAIR REGROWTH TREATMENT	MINOXIDIL	Amazon.com Services LLC	0ce77e6b-c4cf-49e2-8fd9-183286c26f8a	2026-09-08	Warnings	Name fallback generic name: MINOXIDIL
EITIKO Minoxidil Hair Regrowth Treatment	MINOXIDIL	Guangzhou Ariel Medical Technology Co., Ltd.	5aa2a552-f8b5-f11a-e063-6394a90abb1a	2026-09-04	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Foam	MINOXIDIL	HONG KONG YUEJIE INTERNATIONAL TRADING LIMITED	5a7b2dec-4879-7491-e063-6394a90a874f	2026-09-02	Warnings	Name fallback generic name: MINOXIDIL
HAIR REGROWTH TREATMENT	MINOXIDIL	Amazon.com Services LLC	728db7d9-3f38-4006-8024-018f0d9c96da	2026-08-31	Warnings	Name fallback generic name: MINOXIDIL
MINOXIDIL 5% (FOR MEN)	MINOXIDIL	Better Living Brands, LLC	53e33414-2aa4-3dbd-e063-6294a90a06b5	2026-08-27	Warnings	Name fallback generic name: MINOXIDIL
MINOXIDIL 5% TOPICAL AEROSOL60g	MINOXIDIL	Shenzhen Joyuflsh Technology Co.,Ltd.	5a03675b-0bfd-7058-e063-6294a90acf4d	2026-08-27	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	American Health Packaging	0b4fc036-9497-442b-b629-c4b386932789	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Minoxidil Hair Regrowth Treatment	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	59b4f9e3-c241-6a70-e063-6294a90a364f	2026-08-23	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil Hair Regrowth Treatment	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	59b52a52-dab0-87b5-e063-6294a90a0596	2026-08-23	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil Hair Regrowth Treatment	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	59b67ce0-3546-c18a-e063-6394a90ae50a	2026-08-23	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil hair growth Serum	MINOXIDIL	Guangzhou Huanmei Cosmetics Co., Ltd.	597582b0-cfcc-f7b7-e063-6394a90a0e9a	2026-08-20	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	75b2832c-0a6c-4125-9514-19a6d8dbf6cf	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	8ccd07ab-07ed-4b42-b182-3d22b98abca7	2026-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
KIRKLAND SIGNATURE MINOXIDIL	MINOXIDIL	Costco Wholesale Company	90137bb7-f0e3-4c3c-9cfb-d4d5eed13a9c	2026-08-20	Warnings	Name fallback generic name: MINOXIDIL
apgwgzminoxidil5%	MINOXIDIL	Guangdong Jiaoyu Biotechnology Co., Ltd	596d0b43-5cb1-be25-e063-6394a90abbed	2026-08-19	Warnings	Name fallback generic name: MINOXIDIL
apgwgzminoxidil2%	MINOXIDIL	Guangdong Jiaoyu Biotechnology Co., Ltd	5957c990-e274-6278-e063-6394a90af2b7	2026-08-18	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Keranique	4af782f4-68d5-4338-a0a6-85d11a23ce98	2026-08-18	Warnings	Name fallback generic name: MINOXIDIL
Olivita Extra Strength Minoxidil	MINOXIDIL	Olivita Beauty Inc	b2da549b-eb79-46ed-aaec-87326c4a1fbe	2026-08-17	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	P & L Development, LLC	869ce741-3094-4123-9059-0669f3591b2f	2026-08-06	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