Application 019501

Type: NDA
Sponsor: JOHNSON AND JOHNSON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ROGAINE (FOR MEN)	MINOXIDIL	SOLUTION;TOPICAL	2%	Yes	Yes
003	ROGAINE (FOR WOMEN)	MINOXIDIL	SOLUTION;TOPICAL	2%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N019501-002	ROGAINE (FOR MEN)	MINOXIDIL	2%	SOLUTION / TOPICAL		RLD, RS	1996-02-09
N019501-003	ROGAINE (FOR WOMEN)	MINOXIDIL	2%	SOLUTION / TOPICAL		RLD, RS	1996-02-09

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019501-002	ROGAINE (FOR MEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N019501-003	ROGAINE (FOR WOMEN)	2%	SOLUTION / TOPICAL	RLD, RS	1996-02-09	`f41ea6bd6efb…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Womens Rogaine Unscented	MINOXIDIL	Kenvue Brands LLC	8bf0000c-95f3-4a4d-830b-f5ac1539823d	2024-09-06	Warnings	Exact identifier application applno (NDA): 019501 application number: NDA019501 ndc (product): 69968-0090

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69968-0090	Womens Rogaine Unscented	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current
69968-0090	Womens Rogaine Unscented	Minoxidil	Johnson & Johnson Consumer Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84766	SUPPL	2026-01-15
84759	SUPPL	2026-01-15
11514	SUPPL	2015-04-29
1347	SUPPL	2015-04-29
40914	SUPPL	2011-09-22
33761	SUPPL	2005-06-23
33760	SUPPL	2005-06-23
1346	SUPPL	2005-06-23
1345	SUPPL	2005-06-23
17419	SUPPL	2004-06-30