Application 074924

Type: ANDA
Sponsor: APOTEX INC

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
002	MINOXIDIL (FOR WOMEN)	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074924-001	MINOXIDIL (FOR MEN)	MINOXIDIL	2%	SOLUTION / TOPICAL			1998-04-29
A074924-002	MINOXIDIL (FOR WOMEN)	MINOXIDIL	2%	SOLUTION / TOPICAL			1998-04-29

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 · 86 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	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074924-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1998-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074924-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	1998-04-29	`74a2ff9319b5…`

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 3 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5% Minoxidil(For Men)	MINOXIDIL	Guangzhou Ariel Medical Technology Co., Ltd.	55d59902-5461-d604-e063-6394a90a292e	2026-07-04	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil Hair Growth Serum	MINOXIDIL	Guangzhou Ariel Medical Technology Co., Ltd.	5588032c-c5f7-6339-e063-6294a90a36e7	2026-07-01	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil Hair Regrowth Kit	MINOXIDIL	Guangzhou Zeus E-commerce Co., Ltd	550bce76-4c78-80f0-e063-6394a90ad58f	2026-06-24	Warnings	Name fallback generic name: MINOXIDIL
carols daughter hair regrowth treatment	MINOXIDIL	L'Oreal USA Products Inc.	9701797c-76bb-44d4-b28a-2c15a4444b41	2026-06-23	Warnings	Name fallback generic name: MINOXIDIL
Nuvarra Mens Minoxidil Hair Regrowth Treatment	MINOXIDIL	Bionetics Health LLC	6b11b347-6a07-4998-b127-1edfad4965d7	2026-06-17	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Shenzhen Joyuflsh Technology Co.,Ltd.	540b9a4a-5591-8276-e063-6294a90ac516	2026-06-12	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Par Health USA, LLC	8f3800f0-b6da-4dfe-8c32-39bb5eb0262a	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Gemachlich ZuHause Beard Growth Treatment Serum	MINOXIDIL	Guangzhou Xinhongda Trading Service Co., Ltd.	53bb4ef6-bc05-da79-e063-6394a90a3f7e	2026-06-08	Warnings	Name fallback generic name: MINOXIDIL
MINOXIDIL (FOR MEN)	MINOXIDIL	FlexiGo Inc	53793182-8a03-1b0f-e063-6294a90acca6	2026-06-04	Warnings	Name fallback brand name: MINOXIDIL (FOR MEN) generic name: MINOXIDIL
Minoxidil Hair Growth Serum	MINOXIDIL	Shenzhen Deshijian Medical Equipment Co., Ltd	535cdf78-90bc-86b4-e063-6294a90a2c20	2026-06-04	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Regrowth Serum With Biotin	MINOXIDIL	Lianjiang Shanlilai E-commerce Co., Ltd.	5356bc3d-7bba-8e97-e063-6394a90af9c8	2026-06-03	Warnings	Name fallback generic name: MINOXIDIL
HAIRFX HAIR GROWTH FOAM	MINOXIDIL	Guangzhou Jianyuan Biological Technology.Co.,Ltd	dec7249c-e1f9-b5eb-e053-2995a90acf37	2026-05-24	Warnings	Name fallback generic name: MINOXIDIL
SOTI HAIR GROWTH SERUM	MINOXIDIL	Guangzhou Jianyuan Biological Technology Co., Ltd.	0d8beb7c-48be-54de-e063-6394a90a4149	2026-05-24	Warnings	Name fallback generic name: MINOXIDIL
Hair regrowth treatment	MINOXIDIL	Guangzhou Jianyuan Biological Technology.Co.,Ltd	eb87ff2d-7708-4c4d-e053-2a95a90ac72b	2026-05-24	Warnings	Name fallback generic name: MINOXIDIL
Regenivade Hair Growth Foam	MINOXIDIL	Guangzhou Jianyuan Biological Technology.Co.,Ltd	085de93f-dae3-9964-e063-6394a90a5853	2026-05-24	Warnings	Name fallback generic name: MINOXIDIL
ELEVATE HAIR GROWTH SERUM	MINOXIDIL	Guangzhou Jianyuan Biological Technology.Co.,Ltd	0bab4001-f409-695f-e063-6294a90a1717	2026-05-24	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Regrowth Treatment	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	5278c9c2-4bce-fed4-e063-6394a90a7f33	2026-05-23	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil Hair Regrowth Treatment	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	527902b1-2018-4546-e063-6394a90a7052	2026-05-23	Warnings	Name fallback generic name: MINOXIDIL
Mens Jivexa Extra Strength Minoxidil	MINOXIDIL	SMC Essentials LLC	7f77f4de-e66a-4352-a6d3-809c78824953	2026-05-14	Warnings	Name fallback generic name: MINOXIDIL
Foligain Professional Series Extra Strength For Men Minoxidil Hair Regrowth Treatment	MINOXIDIL	WR Group, Inc.	9eac6012-4db8-455e-a60c-bb06c70884cf	2026-05-13	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
30718	ORIG	1998-04-29