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 13 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	Walgreen Company	39526f7d-5e39-4e2e-8689-94b76ddbc462	2022-10-10	Warnings	Name fallback brand name: Minoxidil (For Men) generic name: MINOXIDIL
Minoxidil (For Women)	MINOXIDIL	Walgreen Company	8a32828d-1591-478d-aed3-5159232675b4	2022-10-10	Warnings	Name fallback generic name: MINOXIDIL
hers hair regrowth treatment	MINOXIDIL	Hims Inc	77b917ec-65ea-4c7c-941e-fc37f598294b	2022-04-18	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil 5% (For Men)	MINOXIDIL	Thirty MADISON, Inc.	985ba944-147c-4207-b34b-ede702c3d704	2022-04-01	Warnings	Name fallback generic name: MINOXIDIL
equate hair regrowth treatment	MINOXIDIL	Wal-Mart Stores Inc	b5327990-654f-4c1f-8cd4-95470f12d767	2022-03-09	Warnings	Name fallback generic name: MINOXIDIL
hair regrowth treatment	MINOXIDIL	Walgreen Company	81eb8a45-2997-4614-8f95-215529a1b562	2022-02-24	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil 5 Percent (For Women)	MINOXIDIL	PROFECTUS BEAUTY LLC	b307bcb7-4659-4dd7-86aa-00b3735f5844	2022-01-18	Warnings	Name fallback generic name: MINOXIDIL
equate hair regrowth treatment	MINOXIDIL	Wal-Mart Stores Inc	98f780ad-dc07-4d37-a05d-fc7b45b0c474	2021-09-29	Warnings	Name fallback generic name: MINOXIDIL
Good Sense Hair Regrowth Treatment	MINOXIDIL	L. Perrigo Company	6f939158-eb96-4479-9a4a-f5a11aa88295	2021-09-13	Warnings	Name fallback generic name: MINOXIDIL
basic care hair regrowth treatment	MINOXIDIL	Amazon.com Services LLC	89f70638-619f-4bc6-806e-5f685fdcb379	2021-08-27	Warnings	Name fallback generic name: MINOXIDIL
Womens Minoxidil Hair Growth System	MINOXIDIL	Topiderm, Inc.	6cd3532a-1c1d-44bb-9f7e-c9dc085e2f96	2021-04-23	Warnings	Name fallback generic name: MINOXIDIL
MINOXIDIL	MINOXIDIL	Aphena Pharma Solutions - Tennessee, LLC	0dada91c-fa1c-4da4-ac0d-e68b017c8604	2017-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Regenpure Precision	MINOXIDIL	Salonceuticals, Inc.	4a113921-b2a9-42cc-e054-00144ff8d46c	2017-03-06	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