Application 074643

Type: ANDA
Sponsor: BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOXIDIL (FOR MEN)	MINOXIDIL	SOLUTION;TOPICAL	2%	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074643-001	MINOXIDIL (FOR MEN)	MINOXIDIL	2%	SOLUTION / TOPICAL			1996-04-09

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074643-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-09	`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 4 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Foligain Professional Series Extra Strength for Women Minoxidil Topical Hair Regrowth Treatment	MINOXIDIL	WR Group, Inc.	a765cc59-ab59-4e49-ba28-926a2e0a78b1	2026-05-13	Warnings	Name fallback generic name: MINOXIDIL
equate hair regrowth treatment	MINOXIDIL	WALMART INC.	fd67b4d2-e71d-4145-bf69-437d0aa86cd3	2026-05-12	Warnings	Name fallback generic name: MINOXIDIL
hair regrowth treatment	MINOXIDIL	CVS Pharmacy	57cd1b56-e120-488f-951a-26e447aa4657	2026-05-08	Warnings	Name fallback generic name: MINOXIDIL
hair regrowth treatment for men	MINOXIDIL	CVS Pharmacy	f6320d33-92b1-44ef-97d8-56e78e83d417	2026-05-08	Warnings	Name fallback generic name: MINOXIDIL
RootVive Mens Hair Regrowth Treatment Extra Strength Minoxidil	MINOXIDIL	TrueRoot Labs LLC	de865d37-d99f-4f9d-8c09-472a308e2e91	2026-05-06	Warnings	Name fallback generic name: MINOXIDIL
Mens Extra Strength Minoxidil Hair Growth Treatment	MINOXIDIL	Hairmax International, LLC	7ee426fe-7a13-4327-b333-9651d6871a73	2026-04-30	Warnings	Name fallback generic name: MINOXIDIL
Hair Growth Serum Roll-ON	MINOXIDIL	FlexiGo Inc	506c0a1b-b461-d535-e063-6294a90a4d20	2026-04-27	Warnings	Name fallback generic name: MINOXIDIL
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUM	MINOXIDIL	Putian Licheng District Zhijiancheng Trading Co., Ltd.	5009b231-23c3-7356-e063-6394a90a569f	2026-04-22	Warnings	Name fallback generic name: MINOXIDIL
MINOXIDIL FOR WOMEN	MINOXIDIL	CARDINAL HEALTH 110, LLC. DBA LEADER	33f9e0de-dff1-4a14-8aec-8c842bf34c31	2026-04-13	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	f76f6a05-11f8-48a6-98a3-b1407c228089	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
MINOXIDIL FOR MEN	MINOXIDIL	CARDINAL HEALTH 110, LLC. DBA LEADER	a592317d-bc7c-4c69-a3bf-74d57cd36e3a	2026-04-13	Warnings	Name fallback generic name: MINOXIDIL
up and up hair regrowth treatment for men	MINOXIDIL	Target Corporation	545e3e21-6333-4d85-8754-b7a6201234b7	2026-04-09	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil (For Women)	MINOXIDIL	CVS Pharmacy	b10eb8fd-8301-4c38-af4c-220fe5c3b592	2026-04-06	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil (For Men)	MINOXIDIL	CVS Pharmacy	f6d90382-dc51-480c-a46c-bad041915d07	2026-04-06	Warnings	Name fallback brand name: Minoxidil (For Men) generic name: MINOXIDIL
TAGOQHIA Minoxidil Hair Thickening Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	4e8a913d-8c47-5948-e063-6394a90ad874	2026-04-03	Warnings	Name fallback generic name: MINOXIDIL
good sense hair regrowth treatment	MINOXIDIL	L. Perrigo Company	90e55b8a-11db-48b2-b2a0-48fd8870714d	2026-03-30	Warnings	Name fallback generic name: MINOXIDIL
hair regrowth treatment	MINOXIDIL	Meijer Distribution Inc	a8a2b3c1-ecda-4fc9-b3fd-bb94cfee6e80	2026-03-25	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil For Women	MINOXIDIL	BosleyMD	ebda6e49-140c-4ab0-b155-5ed501ef3e8a	2026-03-24	Warnings	Name fallback generic name: MINOXIDIL
Tacruitf 5% minoxidil with biotin topical solution	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	4dc2850a-9a7e-660f-e063-6294a90afd94	2026-03-24	Warnings	Name fallback generic name: MINOXIDIL
AGIKENB 5% minoxidil with biotin topical solution	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	4dc2be0b-59f1-50fd-e063-6294a90a6f54	2026-03-24	Warnings	Name fallback generic name: MINOXIDIL

Reported adverse events (FAERS/openFDA)#

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