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 2 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL	P & L Development, LLC	869ce741-3094-4123-9059-0669f3591b2f	2026-08-06	Warnings	Name fallback generic name: MINOXIDIL
GOOD SENSE HAIR REGROWTH TREATMENT	MINOXIDIL	L. Perrigo Company	b1bf381e-8f13-4a7e-a2f6-ba750d4d67e7	2026-08-06	Warnings	Name fallback generic name: MINOXIDIL
Good Sense Hair Regrowth Treatment	MINOXIDIL	L. Perrigo Company	a3bfdd6f-2b41-406e-8a20-c1e5de0c186b	2026-08-04	Warnings	Name fallback generic name: MINOXIDIL
INTELLIGENT Mens Minoxidil Extra Strength 5 Minoxidil	MINOXIDIL	INTELLIGENT ELEPHANT, LLC	b9156b21-b410-45ae-a9f0-517e427f5e9b	2026-08-03	Warnings	Name fallback generic name: MINOXIDIL
JOHNSON FOAM	MINOXIDIL	JOHNSON BIOPHARMACEUTICAL INC.	1d44a75c-c940-680c-e063-6394a90a5839	2026-08-02	Warnings	Name fallback generic name: MINOXIDIL
Follicly Minoxidil Hair Regrowth Treatment	MINOXIDIL	Follicly LLC	7cc287ea-d5d3-4bd6-b118-e103992126f9	2026-07-30	Warnings	Name fallback generic name: MINOXIDIL
Clevariel Minoxidil Hair Growth Serum	MINOXIDIL	Guangzhou Ariel Medical Technology Co., Ltd.	57cfd24c-19ab-b9bb-e063-6394a90aa835	2026-07-30	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Topical Solution	MINOXIDIL	Yiwu Pu Feather Trading Co., LTD	57bbba24-6795-c914-e063-6394a90aa1ae	2026-07-29	Warnings	Name fallback generic name: MINOXIDIL
5%Minoxidil Hair Growth Serum	MINOXIDIL	Guangzhou Binsi Clothing Co.,Ltd.	2f7ec62f-fad5-6862-e063-6394a90abe54	2026-07-20	Warnings	Name fallback generic name: MINOXIDIL
5%Minoxidil Hair Growth Sprays Serum	MINOXIDIL	Guangzhou Binsi Clothing Co.,Ltd.	2f7f3b80-48d8-9e24-e063-6394a90a43f5	2026-07-20	Warnings	Name fallback generic name: MINOXIDIL
5%Minoxidil Topical Aerosol(For Men)	MINOXIDIL	Guangzhou Binsi Clothing Co.,Ltd.	3514a9f1-d343-9312-e063-6394a90ac16c	2026-07-20	Warnings	Name fallback generic name: MINOXIDIL
5%MINOXIDIL TOPICAL FOAM	MINOXIDIL	Veloce Trading Co., Limited	56f87881-653f-17e6-e063-6294a90a6787	2026-07-19	Warnings	Name fallback generic name: MINOXIDIL
MINOXIDIL	MINOXIDIL	PD-Rx Pharmaceuticals, Inc.	5fea137a-bc88-4b24-85db-538c90ad1870	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
MINOXIDIL	MINOXIDIL	PD-Rx Pharmaceuticals, Inc.	f0dae476-8d0b-4d0c-a505-ad51bf27a1c8	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	665cba3d-5f26-468a-a047-188a413fbede	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	b138c404-028c-4a73-a127-c96f2072e1f8	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	e39469e6-d4f6-450f-872c-6f538e67c71a	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Preferred Pharmaceuticals Inc.	cdfd3330-4836-4655-80a2-441380529a67	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	934508f8-9252-4d48-ae91-0ce96454dc7b	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Golden State Medical Supply, Inc.	1d134237-3e94-258e-e063-6294a90af556	2026-07-06	Boxed warning, Warnings, Adverse reactions	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