Application 074731

Type: ANDA
Sponsor: HI TECH PHARMA

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
A074731-001	MINOXIDIL (FOR MEN)	MINOXIDIL	2%	SOLUTION / TOPICAL			1996-12-24
A074731-002	MINOXIDIL (FOR WOMEN)	MINOXIDIL	2%	SOLUTION / TOPICAL			2005-05-11

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	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`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 6 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OpusMeds Extra Strength Minoxidil	MINOXIDIL	Opus Meds LLC	eab00b6d-d49a-4090-8243-ae5e99f6a54e	2026-01-26	Warnings	Name fallback generic name: MINOXIDIL
MINOXIDIL 5% (FOR WOMEN)	MINOXIDIL	Aurohealth LLC	dbda95f2-11a8-4b2f-af45-b791342fff70	2026-01-22	Warnings	Name fallback generic name: MINOXIDIL
MINOXIDIL 5% (FOR MEN)	MINOXIDIL	Aurohealth LLC	e6b3b997-cde9-476d-b08c-4d1010456d8b	2026-01-22	Warnings	Name fallback generic name: MINOXIDIL
MINOXIDIL	MINOXIDIL	AvKARE	02d7399f-94cc-f718-f214-587301edd138	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
REGOXIDINE (FOR WOMEN)	MINOXIDIL	INNOVUS PHARMACEUTICALS, INC.	9c06c34d-5a09-47ed-b969-cc81f4ed61ab	2026-01-20	Warnings	Name fallback generic name: MINOXIDIL
REGOXIDINE (FOR MEN)	MINOXIDIL	INNOVUS PHARMACEUTICALS, INC.	d191b3a9-0fb7-45cc-82a1-b64a79c0c125	2026-01-20	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	NuCare Pharmaceuticals, Inc.	2e5a2976-06fb-43f9-e063-6294a90a3bf5	2026-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Hair Regen Hair Growth Treatment	MINOXIDIL	YIWUYIZHOUTRADINGCO.,LTD	15ac989a-6602-d6ec-e063-6294a90a8a48	2026-01-04	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Topical Solution	MINOXIDIL	Yiwu Pu Feather Trading Co., LTD	473c555b-de13-56d5-e063-6394a90a377f	2025-12-31	Warnings	Name fallback generic name: MINOXIDIL
Dr. Bosley Minoxidil (For Men) Hair Regrowth Treatment	MINOXIDIL	Scientific Hair Research, LLC	94da001e-4f5d-43c3-b5e9-48401203513c	2025-12-09	Warnings	Name fallback generic name: MINOXIDIL
Loesch Hair Regrowth Formula Unscented Topical Solution Extra-Strength for Men	MINOXIDIL	Loesch Laboratory Consultant, INC.	d158d3af-6850-48c0-8355-9df0637684cc	2025-12-03	Warnings	Name fallback generic name: MINOXIDIL
iBeaLee 5-in-1 5% Minoxidil Hair Regrowth Solution	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	449fd486-69e2-2894-e063-6394a90a1421	2025-11-27	Warnings	Name fallback generic name: MINOXIDIL
TNEGHC 5% Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	4376b747-257d-433b-e063-6394a90a8df5	2025-11-13	Warnings	Name fallback generic name: MINOXIDIL
KEEPS MINOXIDIL TOPICAL	MINOXIDIL	THIRTY MADISON INC	4b8c9b60-4cc5-4604-b544-d29401fcab73	2025-11-10	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	A-S Medication Solutions	f00f3370-0313-4ce0-be7d-80db4477d9ae	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	A-S Medication Solutions	6c85c69e-b5af-4e98-aacf-f65ad15d00d7	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
5% minoxidil with biotin topical solution	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	425d9ed2-d04f-5946-e063-6294a90a7649	2025-10-30	Warnings	Name fallback generic name: MINOXIDIL
RDVHDLW 5% Minoxidil Hair Growth Foam with Biotin	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	41ba1c1a-2193-466f-e063-6294a90a18f9	2025-10-22	Warnings	Name fallback generic name: MINOXIDIL
hair regrowth treatment	MINOXIDIL	Rite Aid Corporation	00c83180-0e13-4a07-9ce8-a9cae19a79a3	2025-10-08	Warnings	Name fallback generic name: MINOXIDIL
aromatica hair leave in romero con minoxidil	MINOXIDIL	LABORATORIO MK SRL	4020b4c4-6ee8-4aec-e063-6294a90a785e	2025-10-08	Warnings	Name fallback generic name: MINOXIDIL

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-001	Minoxidil	Minoxidil	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-001	Minoxidil	Minoxidil	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-001	Minoxidil	Minoxidil	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-001	Minoxidil	Minoxidil	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-001	Minoxidil	Minoxidil	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-001	Minoxidil	Minoxidil	Hi-Tech Pharmacal Co., Inc.	ANDA	Current