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 5 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil For Men	MINOXIDIL	BosleyMD	61c41686-81af-4000-94bc-3cf9e71b0f18	2026-03-24	Warnings	Name fallback generic name: MINOXIDIL
hair regrowth treatment	MINOXIDIL	Meijer Distribution Inc	cb6ca477-a626-4889-8d4c-62f06600ebbe	2026-03-19	Warnings	Name fallback generic name: MINOXIDIL
OLIVITA Minoxidil	MINOXIDIL	Shenzhen Xinxin Yunhai Technology Co., Ltd.	4cf37b0b-bbb8-1d9c-e063-6294a90af818	2026-03-13	Warnings	Name fallback generic name: MINOXIDIL
Verdibliss 5% Minoxidil Topical Hair Regrowth Treatment For Men	MINOXIDIL	Guangdong Quadrant Ecological Technology Co., Ltd.	4ca67652-4026-d647-e063-6394a90a34ed	2026-03-10	Warnings	Name fallback generic name: MINOXIDIL
5% MINOXIDIL HAIR REGROWTH SERUM With Biotin	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	4c92193d-8910-be62-e063-6294a90ae28e	2026-03-09	Warnings	Name fallback generic name: MINOXIDIL
Nizoral Hair Regrowth Treatment for Men	MINOXIDIL	Kramer Laboratories	d3260777-d56a-4a35-ac82-b0e8e8021517	2026-03-04	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	P & L Development, LLC	204bab15-47c5-449c-a889-700914b04b61	2026-03-03	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	P & L Development, LLC	04373c29-85f3-4d7d-bbdd-950dcf1a879a	2026-03-03	Warnings	Name fallback generic name: MINOXIDIL
NALIOPI 5% minoxidil with biotin topical solution	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	4b9e16f0-3e39-03f2-e063-6394a90a19df	2026-02-24	Warnings	Name fallback generic name: MINOXIDIL
BEHATMH 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	4b9d581b-7133-5494-e063-6294a90a138c	2026-02-24	Warnings	Name fallback generic name: MINOXIDIL
GOOD SENSE HAIR REGROWTH TREATMENT	MINOXIDIL	L. Perrigo Company	c5a23836-ddda-462a-9638-5dd488ea1588	2026-02-23	Warnings	Name fallback generic name: MINOXIDIL
VENANOCI Minoxidil	MINOXIDIL	Shenzhen Xinxin Yunhai Technology Co., Ltd.	4acc38aa-13da-981b-e063-6294a90aede5	2026-02-14	Warnings	Name fallback generic name: MINOXIDIL
Fete Health Hair Regrowth Treatment for Women	MINOXIDIL	Honest Pharma LLC	93f7a89b-65f1-4a58-af75-2eeb0e47a8f8	2026-02-11	Warnings	Name fallback generic name: MINOXIDIL
MINOXIDIL	MINOXIDIL	Sun Pharmaceutical Industries, Inc.	0354a7f5-5917-44dc-9963-411104008cb5	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Hair-Regen Hair Growth Treatment	MINOXIDIL	Yiwu Yizhou Trading Co., Ltd	1bdfebd0-cca8-1c8b-e063-6294a90a8792	2026-02-05	Warnings	Name fallback generic name: MINOXIDIL
hair regrowth treatment	MINOXIDIL	Meijer, Inc.	5cb0fe8a-996f-4bcf-8282-845ad6c6d819	2026-02-05	Warnings	Name fallback generic name: MINOXIDIL
Womens MinoGrow Hair Regrowth Treatment Minoxidil	MINOXIDIL	Minogro Products, LLC	890c2acf-0c08-4c45-b29f-928b6155ca00	2026-02-03	Warnings	Name fallback generic name: MINOXIDIL
TAGOQHIA 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	49d396bf-f427-7154-e063-6294a90a6043	2026-02-02	Warnings	Name fallback generic name: MINOXIDIL
TRZSFR 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	49d40bf8-3ec1-347c-e063-6294a90a7450	2026-02-02	Warnings	Name fallback generic name: MINOXIDIL
5% MINOXIDIL HAIR REGROWTH SERUM With Biotin	MINOXIDIL	Shenzhen Huayuan Hengsheng Technology Co., Ltd.	49e37010-3afe-119d-e063-6294a90ab74a	2026-02-02	Warnings	Name fallback generic name: MINOXIDIL

Reported adverse events (FAERS/openFDA)#

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